BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Report
- Report Number
- 1920898-2022-00833
- Event Type
- Malfunction
- Date Received
- December 2, 2022
- Date of Event
- November 7, 2022
- Report Date
- December 9, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382908411011
- PMA / PMN Number
- K190054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- 003
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# 2101791. ALL INSPECTION AND CHALLENGES PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.
IT WAS REPORTED THAT 7 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD ISSUES WITH THE NEEDLES PIERCING THROUGH THE SHIELDS IN THE POLYBAGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE THROUGH THE SHIELD OF APPROX 7 SYRINGES, FROM DIFFERENT BAGS, SAME LOT AND SAME BOX."
IT WAS REPORTED THAT 7 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD ISSUES WITH THE NEEDLES PIERCING THROUGH THE SHIELDS IN THE POLYBAGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE THROUGH THE SHIELD OF APPROX 7 SYRINGES, FROM DIFFERENT BAGS, SAME LOT AND SAME BOX."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1760961 | BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 2101791 | 00382908411011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |