WALGREENS THIN INSULIN SYRINGES 1.0ML 31GAUGE 5/16"
Report
- Report Number
- 1920898-2023-00537
- Event Type
- Malfunction
- Date Received
- August 8, 2023
- Date of Event
- July 24, 2023
- Report Date
- August 10, 2023
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00311917048130
- PMA / PMN Number
- K190054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
H6: INVESTIGATION SUMMARY: NO SAMPLES 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# 3030370. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.
B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING WALGREENS THIN INSULIN SYRINGES 1.0ML 31GAUGE 5/16" THERE WAS DIFFICULTY ASPIRATING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLES BEND DURING INJECTION. CONSUMER ALSO REPORTED THAT THE NEEDLE WILL NOT DRAW.
IT WAS REPORTED WHILE USING WALGREENS THIN INSULIN SYRINGES 1.0ML 31GAUGE 5/16" THERE WAS DIFFICULTY ASPIRATING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLES BEND DURING INJECTION. CONSUMER ALSO REPORTED THAT THE NEEDLE WILL NOT DRAW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1689022 | WALGREENS THIN INSULIN SYRINGES 1.0ML 31GAUGE 5/16" | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 3030370 | 00311917048130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |