BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE
Report
- Report Number
- 1920898-2022-00692
- Event Type
- Malfunction
- Date Received
- October 6, 2022
- Date of Event
- September 13, 2022
- Report Date
- December 14, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1200370. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 27-OCT-2022. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 0.3ML, 29 GAUGE, 12.7MM SYRINGES FROM LOT 1200370. THE SYRINGES WERE RETURNED DISASSEMBLED, WITH THE PLUNGER ROD AND CAP REMOVED FROM THE SYRINGE. WHEN INSERTED INTO THE SYRINGE, THE PLUNGER ROD ITSELF REMAINS IN PLACE AND SLIGHTLY RESISTS MOVEMENT UP AND DOWN THE SYRINGE BARREL AS INTENDED. THERE IS NO INDICATION THAT THE PLUNGER ROD WOULD BE CAPABLE OF FALLING OUT OF THE BARREL ON ITS OWN. ADDITIONALLY, THERE ARE NO MARKINGS OR DEFECTS THAT COULD DETAIL PREVIOUS DIFFICULTY WITH THE PLUNGER ROD, AS THE STOPPER REMAINS IN PLACE AND DOES NOT FEATURE ANY DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1200370 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO DIRECTLY CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF SEPARATED PLUNGER RODS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED THE PLUNGER FALLING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: WHEN THE PLUNGER CAP WAS REMOVED, THE PLUNGER ROD WAS SEPARATED FROM THE BARREL. THE SEPARATED PLUNGER ROD HAS BECOME UNSANITARY AND CAN NO LONGER BE USED.
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED THE PLUNGER FALLING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: WHEN THE PLUNGER CAP WAS REMOVED, THE PLUNGER ROD WAS SEPARATED FROM THE BARREL. THE SEPARATED PLUNGER ROD HAS BECOME UNSANITARY AND CAN NO LONGER BE USED.
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED THE PLUNGER FALLING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: WHEN THE PLUNGER CAP WAS REMOVED, THE PLUNGER ROD WAS SEPARATED FROM THE BARREL. THE SEPARATED PLUNGER ROD HAS BECOME UNSANITARY AND CAN NO LONGER BE USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2801167 | BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 1200370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |