BD ULTRA-FINE¿ INSULIN SYRINGE
Report
- Report Number
- 1920898-2022-00723
- Event Type
- Malfunction
- Date Received
- October 20, 2022
- Date of Event
- September 23, 2022
- Report Date
- January 5, 2023
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER PHONE #: (B)(6).
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A SINGLE 0.5ML, 31 GAUGE, 6MM SYRINGE FROM LOT 0083432. THIS SYRINGE HAS HAD ITS THUMBPRESS BROKEN FROM THE PROXIMAL TIP OF THE PLUNGER ROD. ADDITIONALLY, THE PLUNGER CAP¿S BASE IS COMPRESSED TO THE POINT THAT IT HAS SPLIT IN CERTAIN SPOTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083432. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF PLUNGER CAP DAMAGE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H10
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# 0083432. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE PROTECTIVE CAP WAS DENTED, WHICH IS A LOSS OF STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PROTECTIVE COVER OF THE PLUNGER WAS DENTED.
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE PROTECTIVE CAP WAS DENTED, WHICH IS A LOSS OF STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PROTECTIVE COVER OF THE PLUNGER WAS DENTED.
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE PROTECTIVE CAP WAS DENTED, WHICH IS A LOSS OF STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PROTECTIVE COVER OF THE PLUNGER WAS DENTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377751 | BD ULTRA-FINE¿ INSULIN SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 0083432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |