BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Report
- Report Number
- 1920898-2022-00033
- Event Type
- Malfunction
- Date Received
- January 24, 2022
- Date of Event
- January 4, 2022
- Report Date
- February 17, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903249107
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1242719; MEDICAL DEVICE EXPIRATION DATE: 09/30/2026; DEVICE MANUFACTURE DATE: 08/30/2021. MEDICAL DEVICE LOT #: 1197248; MEDICAL DEVICE EXPIRATION DATE: 06/30/2026; DEVICE MANUFACTURE DATE: 07/16/2021. 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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2/7/2022. H.6. INVESTIGATION: CUSTOMER RETURNED (20) LOOSE 3/10CC, 6MM SYRINGES WITH PART OF THE SHELF CARTON FROM LOT # 1242719. CUSTOMER STATES THAT THE SYRINGES HAVE A LIQUID THAT COME OUT OF THE NEEDLE WHEN MOVED THE PLUNGER ROD. ALL RETURNED SYRINGES WERE EXAMINED AND 8 OUT OF 20 SAMPLES EXHIBITED A SMALL DROPLET OF MATERIAL COMING OUT OF THE CANNULA WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. CUSTOMER STATES THAT THE PLUNGER STOPPER IS NOT STRAIGHT. ALL RETURNED SYRINGES WERE EXAMINED AND 5 OUT OF 20 SAMPLES EXHIBITED A DEFORMED STOPPER IN THE BARREL. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FROM LOT # 1197248 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1197248 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1242719 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. MAINTENANCE DISPATCH (L2L) WAS CREATED FOR POTENTIAL DRY BARRELS. DRY BARRELS INDICATE A LACK OF SILICONE INSIDE THE BARREL TO ALLOW MOVEMENT OF THE PLUNGER/STOPPER ROD. FOUND A SILICONE GUN NOT ALIGNED CORRECTLY. NO ROOT CAUSE AS TO WHY THE GUN WAS SIGHTLY OUT OF LINE TO THE SILICONE BEING APPLIED INTO THE BARREL.
IT WAS REPORTED THAT WHILE USING THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, FOREIGN LIQUID CAME OUT OF THE NEEDLE, AND THE PLUNGER ROD WAS NOT STRAIGHT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED OUT OF THE TWO BOXES LISTED FOUND SYRINGES TO HAVE A LIQUID THAT COME OUT OF THE NEEDLE WHEN MOVED THE PLUNGER ROD. (LOT #: 1242719 & 1197248). CONSUMER REPORTED WITH ONE OF THE ABOVE BOXES - ALSO FINDING THE PLUNGER STOPPER TO BE NOT STRAIGHT. (LOT #: 1242719).
IT WAS REPORTED THAT WHILE USING THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, FOREIGN LIQUID CAME OUT OF THE NEEDLE, AND THE PLUNGER ROD WAS NOT STRAIGHT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED OUT OF THE TWO BOXES LISTED FOUND SYRINGES TO HAVE A LIQUID THAT COME OUT OF THE NEEDLE WHEN MOVED THE PLUNGER ROD. (LOT #: 1242719 & 1197248). CONSUMER REPORTED WITH ONE OF THE ABOVE BOXES - ALSO FINDING THE PLUNGER STOPPER TO BE NOT STRAIGHT. (LOT #: 1242719).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1242541 | BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 324910 | SEE H.10. | 00382903249107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |