SYRINGES 0.3ML 31G 6MM S/C U-100 RELION
Report
- Report Number
- 1920898-2022-00023
- Event Type
- Malfunction
- Date Received
- January 21, 2022
- Date of Event
- December 29, 2021
- Report Date
- March 3, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00681131138390
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES, D.9. RETURNED TO MANUFACTURER ON: 2/7/2022. H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 0.3ML INSULIN SYRINGE. THE CONSUMER REPORTED PLUNGER ROD DAMAGED, AND STATED THAT THE THUMB PRESS IS INCORRECTLY ATTACHED-SAID THAT IT IS ON THE SIDE OF THE PLUNGER ROD RATHER THAN ON THE TOP. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE PLUNGER ROD WAS BROKEN AT THE THUMBPRESS. NO DAMAGE TO THE PLUNGER CAP OR BARREL WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1123335. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND 1 DISPATCH WAS OPENED FOR PLUNGER JAMS / NOT FEEDING DOWN THE RAIL. THE PLUNGERS ARE GUIDED DOWN A RAIL BY THE PLUNGER HEAD. WHEN A JAM OCCURS, THE PLUNGERS ARE REMOVED HOWEVER IT THE JAM IS MINOR AND DISSIPATES ON ITS OWN, IT MAY HAVE WEAKENED THE PLUNGER HEAD PRIOR TO ASSEMBLING THE SYRINGE.
H.6. INVESTIGATION: 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# 1123335. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE FOUR (4) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.
IT WAS REPORTED THAT 2 SYRINGES 0.3ML 31G 6MM S/C U-100 RELION HAD PRODUCT DAMAGE AND DEVICE STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED PLUNGER ROD DAMAGED AND STATED THAT THE THUMB PRESS IS INCORRECTLY ATTACHED BEING THAT IT IS ON THE SIDE OF THE PLUNGER ROD RATHER THAN ON THE TOP. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.
IT WAS REPORTED THAT 2 SYRINGES 0.3ML 31G 6MM S/C U-100 RELION HAD PRODUCT DAMAGE AND DEVICE STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED PLUNGER ROD DAMAGED AND STATED THAT THE THUMB PRESS IS INCORRECTLY ATTACHED BEING THAT IT IS ON THE SIDE OF THE PLUNGER ROD RATHER THAN ON THE TOP. DATE OF EVENT : UNKNOWN, SAMPLES : AVAILABLE.
IT WAS REPORTED THAT 2 SYRINGES 0.3ML 31G 6MM S/C U-100 RELION HAD PRODUCT DAMAGE AND DEVICE STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED PLUNGER ROD DAMAGED AND STATED THAT THE THUMB PRESS IS INCORRECTLY ATTACHED BEING THAT IT IS ON THE SIDE OF THE PLUNGER ROD RATHER THAN ON THE TOP. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808356 | SYRINGES 0.3ML 31G 6MM S/C U-100 RELION | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 1123335 | 00681131138390 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |