BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR
Report
- Report Number
- 1920898-2023-00437
- Event Type
- Malfunction
- Date Received
- July 12, 2023
- Date of Event
- June 18, 2023
- Report Date
- November 2, 2023
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 14-JUL-2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A FULL SHELF CARTON WITH 31GA 6MM SYRINGES.TWO OF THE POLYBAGS WERE RETURNED OPEN. CUSTOMER STATED THAT "A THIN BLACK LINE AND BLACK DOTS ARE ON THE NEEDLE SURFACE. THE SYRINGES FROM THE OPEN BAGS WERE VISUALLY INSPECTED UNDER THE MICROSCOPE AND SMALL BLACK MARKS WERE OBSERVED ON THE CANNULA SURFACES THAT LOOKED LIKE DISCOLORATION OF THE CANNULA METAL. THE CANNULA WAS SCRAPED USING THE SAFETY KNIFE, AND WE WERE NOT ABLE TO GET ANY FOREIGN MATERIAL FROM THE BLACK LINES ON THE CANNULA SURFACE FOR FTIR TESTING. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER-INDICATED FAILURE BLACK MARKS ON THE CANNULA SURFACE.
CORRECTION: H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 2ND COMPLAINT FOR LOT 2213126 AND THE 4TH COMPLAINT FOR THE REPORTED LOT NUMBER 2199495. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2213126 D4. MEDICAL DEVICE EXPIRATION DATE: 31AUG2027 H4. DEVICE MANUFACTURE DATE: 01AUG2022 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 BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FM ISSUE - BLACK LINE AND DOT ON THE NEEDLE SURFACE CUSTOMER STATED THAT "A THIN BLACK LINE AND BLACK DOTS ARE ON THE NEEDLE SURFACE."
IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FM ISSUE - BLACK LINE AND DOT ON THE NEEDLE SURFACE CUSTOMER STATED THAT "A THIN BLACK LINE AND BLACK DOTS ARE ON THE NEEDLE SURFACE."
IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FM ISSUE - BLACK LINE AND DOT ON THE NEEDLE SURFACE CUSTOMER STATED THAT "A THIN BLACK LINE AND BLACK DOTS ARE ON THE NEEDLE SURFACE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2170247 | BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BD MEDICAL - DIABETES CARE | 2199495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |