SYRINGE 0.5ML 31G 6MM S/C U-100 RELION
Report
- Report Number
- 1920898-2020-01703
- Event Type
- Malfunction
- Date Received
- December 10, 2020
- Date of Event
- November 17, 2020
- Report Date
- January 29, 2021
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00681131138376
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 12/28/2020. H6: INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 6MM, 31G RELION SYRINGE IN AN OPEN POLY BAG WITH THE SHELF CARTON FROM LOT # 0013117. CUSTOMER STATES THAT THE SYRINGE WOULD NOT DRAW UP INSULIN. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A CRACK IN THE BARREL RANGING FROM THE 0-15 UNIT MARKINGS. THE SYRINGE WAS THEN TESTED AND THE SAMPLE WAS NOT ABLE TO DRAW PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0013117. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200867826, 200872884] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: MAINTENANCE DISPATCHES (L2L) #91297 WAS CREATED ON 10MAR2020 FOR NUMEROUS INDEX JAMS. H3 OTHER TEXT: SEE H10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 12/28/2020. H6: INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 6MM, 31G RELION SYRINGE IN AN OPEN POLY BAG WITH THE SHELF CARTON FROM LOT # 0013117. CUSTOMER STATES THAT THE SYRINGE WOULD NOT DRAW UP INSULIN. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A CRACK IN THE BARREL RANGING FROM THE 0-15 UNIT MARKINGS. THE SYRINGE WAS THEN TESTED AND THE SAMPLE WAS NOT ABLE TO DRAW PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0013117. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200867826, 200872884] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: MAINTENANCE DISPATCHES (L2L) #91297 WAS CREATED ON 10MAR2020 FOR NUMEROUS INDEX JAMS. H3 OTHER TEXT: SEE H10.
IT WAS REPORTED THAT A SYRINGE 0.5ML 31G 6MM S/C U-100 RELION WAS UNABLE TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 1 SYRINGE WOULD NOT DRAW UP INSULIN. VERBATIM: CONSUMER REPORTED FOUND 1 SYRINGE THAT WOULD NOT DRAW UP INSULIN NOR AIR. "
IT WAS REPORTED THAT A SYRINGE 0.5ML 31G 6MM S/C U-100 RELION WAS UNABLE TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 1 SYRINGE WOULD NOT DRAW UP INSULIN. VERBATIM: CONSUMER REPORTED FOUND 1 SYRINGE THAT WOULD NOT DRAW UP INSULIN NOR AIR. "
DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT A SYRINGE 0.5ML 31G 6MM S/C U-100 RELION WAS UNABLE TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT 1 SYRINGE WOULD NOT DRAW UP INSULIN. (VERBATIM:) CONSUMER REPORTED FOUND 1 SYRINGE THAT WOULD NOT DRAW UP INSULIN NOR AIR. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1447175 | SYRINGE 0.5ML 31G 6MM S/C U-100 RELION | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 0013117 | 00681131138376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |