Device product
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509011
Z-1513-2024
Product summary
- Event
- Event 94165
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2726 units
- Official record key
device-enforcement:Z-1513-2024
Official wording
Reason: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Code information: GTIN: 08714729880417 Lot Numbers: 32257549, 32257552, 32267521, 32270820, 32358475, 32358478, 32367048, 32374780, 32374781, 32385061, 32506053, 32506054, 32515036, 32531791, 32545183, 32545184, 32623024, 32802227, 32802228, 32810934, 32810935, 32958981, 32958982 ,32968819, 32970723, 33080372,33080373,33087966 ,33209008
Distribution pattern: Worldwide distribution - US Nationwide and the country of Japan.
Derived failure modes
-
Unknown
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration