BD¿ PET SYRINGES VETERINARY INSULIN SYRINGE
Report
- Report Number
- 1920898-2023-00171
- Event Type
- Malfunction
- Date Received
- March 29, 2023
- Date of Event
- March 13, 2023
- Report Date
- July 20, 2023
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903230006
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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: H6: INVESTIGATION SUMMARY: THE CUSTOMER RETURNED (9) 0.3ML 29GA SYRINGES, REPORTING SCALE MARKINGS AS DEFECTIVE. THE SYRINGES WERE VISUALLY EXAMINED AND OBSERVED SCALE MARKINGS DEFECTIVE ON THE BARREL. UPON VISUAL EXAMINATION, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER-INDICATED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #2003427 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. NO ROOT CAUSE CAN BE DETERMINED.
H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2332719. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2027. DEVICE MANUFACTURE DATE: 28-NOV-2022. MEDICAL DEVICE LOT #: 2003427. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. DEVICE MANUFACTURE DATE: 03-JAN-2022. 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 UNSPECIFIED NUMBER OF BD¿ PET SYRINGES VETERINARY INSULIN SYRINGES FROM LOTS 2332719 AND 2003427 HAD SLANTED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER REPORTED "SCALE MARKINGS" ON SOME OF THE BARRELS ARE NOT STRAIGHT. STATED, THE MARKINGS ARE "SLANTED"? STATED, TWO BOXES AFFECTED"
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ PET SYRINGES VETERINARY INSULIN SYRINGES FROM LOTS 2332719 AND 2003427 HAD SLANTED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER REPORTED "SCALE MARKINGS" ON SOME OF THE BARRELS ARE NOT STRAIGHT. STATED, THE MARKINGS ARE "SLANTED"? STATED, TWO BOXES AFFECTED".
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ PET SYRINGES VETERINARY INSULIN SYRINGES FROM LOTS 2332719 AND 2003427 HAD SLANTED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER REPORTED "SCALE MARKINGS" ON SOME OF THE BARRELS ARE NOT STRAIGHT. STATED, THE MARKINGS ARE "SLANTED"? STATED, TWO BOXES AFFECTED"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177322 | BD¿ PET SYRINGES VETERINARY INSULIN SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 323000 | SEE H10 | 00382903230006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |