BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE
Report
- Report Number
- 1920898-2021-01396
- Event Type
- Malfunction
- Date Received
- January 13, 2022
- Date of Event
- December 16, 2021
- Report Date
- February 11, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-02-07. H6: INVESTIGATION SUMMARY- CUSTOMER RETURNED A 0.5ML SYRINGE WITH NO POUCH FOR IDENTIFICATION. THE SYRINGE HAD ITS NEEDLE SHIELD AND HUB SEPARATE FROM THE BARREL. THE HUB HAS BECOME LODGED INSIDE THE SHIELD. THERE IS NO DAMAGE TO EITHER THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR ITS RESPECTIVE NEEDLE HUB. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1060385. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. BASED ON THE SAMPLE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SHIELD NOT DETACHING AS INTENDED. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.
INVESTIGATION SUMMARY NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. THREE PHOTOS OF A 0.5ML INSULIN SYRINGE FROM LOT# 1060385 WERE PROVIDED. THE CUSTOMER REPORTED THAT THE NEEDLE SHIELDS WERE DIFFICULT TO REMOVE, AND ¿ ONCE REMOVED ¿ THE NEEDLE HUB SEPARATED. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS DETACHED FROM THE SYRINGE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1060385. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.
IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE HUBS SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED 2 NEEDLES THAT THE CAP WOULD NOT COME OFF RESULTING IN ULTIMATELY PULLING THE NEEDLE RIGHT OFF OF THE BARREL AND SEVERAL THAT ACTUALLY NEEDED PLIERS TO REMOVE THE CAP.
IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE HUBS SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED 2 NEEDLES THAT THE CAP WOULD NOT COME OFF RESULTING IN ULTIMATELY PULLING THE NEEDLE RIGHT OFF OF THE BARREL AND SEVERAL THAT ACTUALLY NEEDED PLIERS TO REMOVE THE CAP.
IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE HUBS SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED 2 NEEDLES THAT THE CAP WOULD NOT COME OFF RESULTING IN ULTIMATELY PULLING THE NEEDLE RIGHT OFF OF THE BARREL AND SEVERAL THAT ACTUALLY NEEDED PLIERS TO REMOVE THE CAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1331147 | BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 1060385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |