BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE
Report
- Report Number
- 1920898-2021-01410
- Event Type
- Malfunction
- Date Received
- January 19, 2022
- Date of Event
- December 24, 2021
- Report Date
- February 25, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903249091
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 8043556, D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2023, H.4. DEVICE MANUFACTURE DATE: 8/12/2018. D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2/24/2022. H.6. INVESTIGATION: CUSTOMER RETURNED A SINGLE SYRINGE IN A POLYBAG FOR 0.3ML, 31 GAUGE, 6MM SYRINGES FROM LOT 8043556. 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# 8043556. 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 SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. CAPA#1630423 WAS INITIATED.
H6: INVESTIGATION SUMMARY. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED.
IT WAS REPORTED WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE THE NEEDLE SEPARATED FROM THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324909. IT WAS REPORTED THAT NEEDLE HUB SEPARATES INTO NEEDLE SHIELD. BD VEO INSULIN SYRINGES 3/10 ML,6 MM, 31G FOR U-100 INSULIN THE NEEDLE DEVICE GOT STUCK INTO THE ORANGE CAP AND CAN NOT BE REMOVED. THIS HAPPENED TO TWO MORE SYRINGES MAKING THEM USELESS.
IT WAS REPORTED WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE THE NEEDLE SEPARATED FROM THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324909. IT WAS REPORTED THAT NEEDLE HUB SEPARATES INTO NEEDLE SHIELD. BD VEO INSULIN SYRINGES 3/10 ML,6 MM, 31G FOR U-100 INSULIN THE NEEDLE DEVICE GOT STUCK INTO THE ORANGE CAP AND CAN NOT BE REMOVED. THIS HAPPENED TO TWO MORE SYRINGES MAKING THEM USELESS.
IT WAS REPORTED WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE THE NEEDLE SEPARATED FROM THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324909. IT WAS REPORTED THAT NEEDLE HUB SEPARATES INTO NEEDLE SHIELD. BD VEO INSULIN SYRINGES 3/10 ML,6 MM, 31G FOR U-100 INSULIN THE NEEDLE DEVICE GOT STUCK INTO THE ORANGE CAP AND CAN NOT BE REMOVED. THIS HAPPENED TO TWO MORE SYRINGES MAKING THEM USELESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 635875 | BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 324909 | SEE H.10 | 00382903249091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |