BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
Report
- Report Number
- 1920898-2019-01539
- Event Type
- Malfunction
- Date Received
- January 13, 2020
- Date of Event
- December 27, 2019
- Report Date
- January 30, 2020
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382908466035
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6 INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE (1) LOOSE 30GX12.7MM, 0.5ML BD INSULIN SYRINGE. CONSUMER REPORTED FINDING 2 SYRINGES WITH BENT NEEDLES PRIOR TO USE AND FINDING 2 SYRINGES WITH LOOSE HUBS PRIOR TO USE. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE SYRINGE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. NO EVIDENCE OF A BENT NEEDLE WAS OBSERVED ON THE RETURNED SYRINGE. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES) BUT WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NEEDLE BENT). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9140646 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED FOR RAISED HUBS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A VISUAL EVALUATION OF PHOTO FOUND (1) SYRINGE WITH NO NEEDLE ASSEMBLY ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. THERE WAS NO HUB INSIDE OF THE SHIELD. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. ROOT CAUSE: NOTIFICATION (B)(4) WAS CREATED RAISED HUBS AT JA ASSEMBLY MACHINE. THERE WAS A BAD VALUE ON THE EJECT SHOOT. CORRECTIVE ACTION: VALVE ON EJECT GATE WAS REPLACED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.
IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HAD LOOSE HUBS. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328466, BATCH NO. 9140646. IT WAS REPORTED THAT 2 SYRINGES HAD BENT NEEDLES PRIOR TO USE AND 2 OTHER SYRINGES HAD LOOSE HUBS. VERBATIM: CONSUMER REPORTED FINDING 2 SYRINGES WITH BENT NEEDLES PRIOR TO USE AND FINDING 2 SYRINGES WITH LOOSE HUBS PRIOR TO USE. STATED, WAS NOT ABLE TO USE SYRINGES FOR INJECTIONS.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HAD LOOSE HUBS. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328466, BATCH NO. 9140646. IT WAS REPORTED THAT 2 SYRINGES HAD BENT NEEDLES PRIOR TO USE AND 2 OTHER SYRINGES HAD LOOSE HUBS. VERBATIM: CONSUMER REPORTED FINDING 2 SYRINGES WITH BENT NEEDLES PRIOR TO USE AND FINDING 2 SYRINGES WITH LOOSE HUBS PRIOR TO USE. STATED, WAS NOT ABLE TO USE SYRINGES FOR INJECTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47536 | BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 328466 | 9140646 | 00382908466035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |