RELION® INSULIN SYRINGE
Report
- Report Number
- 1920898-2022-00744
- Event Type
- Malfunction
- Date Received
- October 26, 2022
- Date of Event
- October 3, 2022
- Report Date
- November 10, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00681131311786
- PMA / PMN Number
- K212499
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
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.
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# 2082315. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT SHE RECEIVED MIXED PRODUCT, STATED THAT SHE PURCHASED A BOX OF 8MM, 31G, 3/10ML SYRINGES AND INSIDE OF THE BOX WERE 8 BAGS OF 8MM, 31G, 1ML SYRINGES.
IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT SHE RECEIVED MIXED PRODUCT, STATED THAT SHE PURCHASED A BOX OF 8MM, 31G, 3/10ML SYRINGES AND INSIDE OF THE BOX WERE 8 BAGS OF 8MM, 31G, 1ML SYRINGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2720389 | RELION® INSULIN SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 328512 | 2082315 | 00681131311786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |