BD INSULIN SYRINGE, 3/10ML 31G X 8MM
Report
- Report Number
- 1920898-2021-00013
- Event Type
- Malfunction
- Date Received
- January 8, 2021
- Date of Event
- December 8, 2020
- Report Date
- July 15, 2021
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00311917048154
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHARMACIST
Narratives
H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. H3 OTHER TEXT : SEE H10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/13/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (35) LOOSE 3/10CC, 8MM SYRINGES. CUSTOMER STATES THAT THE PLUNGER DID NOT WORK, THAT THE NEEDLES BROKE AND THAT THE NEEDLES WERE BENDING WHEN INSERTED INTO THE VIAL. ALL RETURNED SYRINGES WERE TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY DEFECTS OBSERVED WITH THE PLUNGER RODS. ALL RETURNED SYRINGES WERE EXAMINED AND NO BROKEN CANNULA WAS OBSERVED. THIRTY OUT OF 35 RETURNED SYRINGES WERE TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD. ALL OBSERVATIONS FELL WITHIN SPECIFICATIONS. UNABLE TO PERFORM DHR CHECK DUE TO UNKNOWN LOT NUMBER. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.
IT WAS REPORTED THAT WHILE USING BD INSULIN SYRINGE, 3/10ML 31G X 8MM THE PLUNGER WAS DIFFICULT TO MOVE AND CANNULA BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI WE HAVE A PATIENT THAT USES OUR INSULIN SYRINGES WIC 654882 NDC 11917-0048-15. THEY HAVE HAD ABOUT 2-5 IN EACH OF THE LAST COUPLE OF BOXES THAT HAVE BEEN DEFECTIVE. THE PLUNGER DID NOT WORK, THE NEEDLES BROKE WERE THE COMMON COMPLAINTS. THEY ARE GOING TO BRING A COUPLE IN IF YOU WOULD LIKE TO INVESTIGATE THEM. HOWEVER, THIS DOES NOT SEEM TO REFLECT HIGH QUALITY AS ADVERTISED.
IT WAS REPORTED THAT WHILE USING BD INSULIN SYRINGE, 3/10ML 31G X 8MM THE PLUNGER WAS DIFFICULT TO MOVE AND CANNULA BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI, WE HAVE A PATIENT THAT USES OUR INSULIN SYRINGES WIC 654882 NDC 11917-0048-15. THEY HAVE HAD ABOUT 2-5 IN EACH OF THE LAST COUPLE OF BOXES THAT HAVE BEEN DEFECTIVE. THE PLUNGER DID NOT WORK, THE NEEDLES BROKE WERE THE COMMON COMPLAINTS. THEY ARE GOING TO BRING A COUPLE IN IF YOU WOULD LIKE TO INVESTIGATE THEM. HOWEVER, THIS DOES NOT SEEM TO REFLECT HIGH QUALITY AS ADVERTISED.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
IT WAS REPORTED THAT WHILE USING BD INSULIN SYRINGE, 3/10ML 31G X 8MM THE PLUNGER WAS DIFFICULT TO MOVE AND CANNULA BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI WE HAVE A PATIENT THAT USES OUR INSULIN SYRINGES WIC 654882 NDC 11917-0048-15. THEY HAVE HAD ABOUT 2-5 IN EACH OF THE LAST COUPLE OF BOXES THAT HAVE BEEN DEFECTIVE. THE PLUNGER DID NOT WORK, THE NEEDLES BROKE WERE THE COMMON COMPLAINTS. THEY ARE GOING TO BRING A COUPLE IN IF YOU WOULD LIKE TO INVESTIGATE THEM. HOWEVER, THIS DOES NOT SEEM TO REFLECT HIGH QUALITY AS ADVERTISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34886 | BD INSULIN SYRINGE, 3/10ML 31G X 8MM | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 928858 | UNKNOWN | 00311917048154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |