RELION INSULIN SYRINGE
Report
- Report Number
- 1920898-2019-00291
- Event Type
- Malfunction
- Date Received
- March 29, 2019
- Date of Event
- March 12, 2019
- Report Date
- May 21, 2019
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00681131311786
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
INVESTIGATION SUMMAY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8211747. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS [200772181, 200771870] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.
H.6. INVESTIGATION: CUSTOMER RETURNED (1) 3/10CC, 8MM, 31G RELION SYRINGE IN AN OPEN POLY BAG FROM LOT # 8211747. CUSTOMER STATES THAT THERE WAS A BUBBLE IN THE BARREL OF THE SYRINGE AND THE BARREL WAS ALSO BENT. THE RETURNED SYRINGE WAS EXAMINED AND NO FOREIGN MATTER WAS OBSERVED IN OR ON THE SAMPLE. HOWEVER, THE SYRINGE DID EXHIBIT A DEFORMED BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8211747. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DEFORMED BARREL). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FOREIGN MATTER). POSSIBLE ROOT CAUSE: LIKELY A JAW JAM OF FORM FILL & SEAL AND THEN MADE IT TO PACKAGING.
IT WAS REPORTED THAT AN AIR BUBBLE WAS SEEN INSIDE THE BENT RELION® INSULIN SYRINGE BARREL BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RELION CONSUMER REPORTED SEEING WHAT LOOKS LIKE A "BUBBLE" IN THE BARREL BEFORE USE. DID NOT USE SYRINGE. STATED THE BARREL IS ALSO BENT. 1 SYRINGE AFFECTED. LOT: 8211747, ITEM: 3/10ML, 31G, 8MM."
IT WAS REPORTED THAT AN AIR BUBBLE WAS SEEN INSIDE THE BENT RELION® INSULIN SYRINGE BARREL BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RELION CONSUMER REPORTED SEEING WHAT LOOKS LIKE A "BUBBLE" IN THE BARREL BEFORE USE. DID NOT USE SYRINGE. STATED THE BARREL IS ALSO BENT. 1 SYRINGE AFFECTED. LOT: 8211747, ITEM: 3/10ML, 31G, 8MM."
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT AN AIR BUBBLE WAS SEEN INSIDE THE BENT RELION® INSULIN SYRINGE BARREL BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RELION CONSUMER REPORTED SEEING WHAT LOOKS LIKE A "BUBBLE" IN THE BARREL BEFORE USE. DID NOT USE SYRINGE. STATED THE BARREL IS ALSO BENT. 1 SYRINGE AFFECTED. LOT: 8211747, ITEM: 3/10ML, 31G, 8MM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260374 | RELION INSULIN SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 8211747 | 00681131311786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |