Device product
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
Z-1666-2014
Product summary
- Event
- Event 68040
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7400
- Official record key
device-enforcement:Z-1666-2014
Official wording
Reason: B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
Code information: catalog no. 333740, lot no. 61358613, exp. 4/30/2015: Sprotte Spinal Tray, 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25% catalog no. 333741, lot no 61352071,exp. 12/31/2018: Sprotte Pencil Point Spinal Needle 24 gauge with Introducer catalog no. 333742, lot no.61350129, exp. 5/31/2015: Sprotte Spinal Tray, 24 gauge with 2mL Lidocaine 5% with Dextrose 7.5% catalog no. 560581, lot no.61354298, exp. 4/30/2015: Sprotte Spinal Tray 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25%
Distribution pattern: Worldwide Distribution - USA (nationwide) and to Canada.
Derived failure modes
-
Unknown
B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.