BD INTEGRA 3 ML SYRINGE W/ DETACHABLE NEEDLE
Report
- Report Number
- 1213809-2019-01078
- Event Type
- Malfunction
- Date Received
- October 29, 2019
- Date of Event
- October 10, 2019
- Report Date
- January 6, 2020
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- MEG
- UDI-DI
- 30382903052722
- PMA / PMN Number
- K011103
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: FOUR PHOTOS WERE RECEIVED AND EVALUATED. TWO PHOTOS DISPLAYED AN OPENED BLISTER PACK FROM BATCH 4051220 (P/N 305272). TWO PHOTOS DISPLAYED A DISASSEMBLED 3ML INTEGRA SYRINGE WITH THE METAL CUTTER EXPOSED. FROM THE PHOTOS PROVIDED IT CANNOT BE DETERMINED WHEN THE RETRACTION MECHANISM WAS ACTIVATED. ADDITIONALLY, THIS BATCH WAS EXPIRED AS OF 2/28/2019. THE REPORTED DEFECT COULD NOT BE CONFIRMED FROM THE EVIDENCE PROVIDED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.
H.6. INVESTIGATION SUMMARY: TWO 3ML INTEGRA SYRINGES FROM BATCH 4051220 (P/N 305272) WERE RECEIVED. ONE SYRINGE WAS IN A FULLY SEALED BLISTER PACK AND ONE WAS IN AN OPENED BLISTER PACK WITH THE NEEDLE REMOVED AND RETRACTION MECHANISM ACTIVATED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. NO SAMPLE EVALUATION COULD BE PERFORMED AS THIS BATCH IS EXPIRED 2/28/2019. H3 OTHER TEXT : SEE SECTION H.10.
MATERIAL NO.: 305272; BATCH NO.: 4051220. IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ 3 ML SYRINGE W/ DETACHABLE NEEDLE A METAL PIECE IN THE PLUNGER PIERCED THE STOPPER RESULTING IN THE MEDICATION LEAKING OUT OF THE BACK OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A ROUND METAL PIECE IN THE PLUNGER PART OF THE SYRINGE PIERCED THE RUBBER STOPPER WHILE ADMINISTERING MY HUSBAND'S INJECTION. MEDICATION RAN OUT OF THE BACK OF THE SYRINGE, SO MY HUSBAND WAS ONLY GIVEN A PARTIAL DOSE OF HIS PRESCRIBED MEDICATION.
MATERIAL NO.: 305272; BATCH NO.: 4051220. IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ 3 ML SYRINGE W/ DETACHABLE NEEDLE A METAL PIECE IN THE PLUNGER PIERCED THE STOPPER RESULTING IN THE MEDICATION LEAKING OUT OF THE BACK OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A ROUND METAL PIECE IN THE PLUNGER PART OF THE SYRINGE PIERCED THE RUBBER STOPPER WHILE ADMINISTERING MY HUSBAND'S INJECTION. MEDICATION RAN OUT OF THE BACK OF THE SYRINGE, SO MY HUSBAND WAS ONLY GIVEN A PARTIAL DOSE OF HIS PRESCRIBED MEDICATION.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
MATERIAL NO.: 305272 BATCH NO.: 4051220. IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ 3 ML SYRINGE W/DETACHABLE NEEDLE A METAL PIECE IN THE PLUNGER PIERCED THE STOPPER RESULTING IN THE MEDICATION LEAKING OUT OF THE BACK OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A ROUND METAL PIECE IN THE PLUNGER PART OF THE SYRINGE PIERCED THE RUBBER STOPPER WHILE ADMINISTERING MY HUSBAND'S INJECTION. MEDICATION RAN OUT OF THE BACK OF THE SYRINGE, SO MY HUSBAND WAS ONLY GIVEN A PARTIAL DOSE OF HIS PRESCRIBED MEDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1047985 | BD INTEGRA 3 ML SYRINGE W/ DETACHABLE NEEDLE | PISTON SYRINGE | MEG | BECTON DICKINSON MEDICAL SYSTEMS | 4051220 | 30382903052722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |