BD MICROTAINER® QUIKHEEL¿ PREEMIE LANCET
Report
- Report Number
- 2618282-2023-00054
- Event Type
- Malfunction
- Date Received
- July 11, 2023
- Date of Event
- April 5, 2023
- Report Date
- July 14, 2023
- Manufacturer
- BD CARIBE LTD.
- Product Code
- FMK
- UDI-DI
- 50382903681001
- PMA / PMN Number
- K223243
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 2259018 D4. MEDICAL DEVICE EXPIRATION DATE: 31-08-2027 H4. DEVICE MANUFACTURE DATE: 27-10-2022, D4. MEDICAL DEVICE LOT#: 2259021 D4. MEDICAL DEVICE EXPIRATION DATE: 31-08-2027 H4. DEVICE MANUFACTURE DATE: 27-10-2022, D4. MEDICAL DEVICE LOT#: 2291751 D4. MEDICAL DEVICE EXPIRATION DATE: 30-09-2027 H4. DEVICE MANUFACTURE DATE: 27-10-2022, H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY "MATERIAL #: 368100. LOT/BATCH #: 2259018, 2259021, 2291751. BD HAD NOT RECEIVED SAMPLES, BUT 12 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR INCORRECT BARCODE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY OF EACH REPORTED LOT NUMBER WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING, EACH HAVING THEIR BARCODES SCANNED, AND NO ISSUES WERE OBSERVED RELATING TO INCORRECT BARCODE AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE INCORRECT BARCODE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."
IT WAS REPORTED THAT WHILE USING BD MICROTAINER® QUIKHEEL¿ PREEMIE LANCET THERE WAS INCORRECT LABEL INFORMATION OF THREE LABELS. THREE LOT NUMBERS WERE AFFECTED. THERRE WAS NO REPORT OF PATIENT IMPACT. "WHEN THE BARCODES ON THE CASE BARCODE LABEL OF THE LOTS (CAT#368100/LOT#2259018, 2259021, 2291751) WERE READ BY KEYENCE SCANNERS, IT WAS POSSIBLE TO READ THEM, BUT THE LOT NUMBER AND THE EXPIRATION DATE WERE DETERMINED INCORRECTLY. AFTER CHECKING THE READ BARCODE INFORMATION, IT WAS CONSIDERED THAT THE BARCODE COULD NOT BE IDENTIFIED CORRECTLY BECAUSE AN ILLEGAL CHARACTER "!" OR "T" WAS ENTERED AT THE END OF THE BARCODE NUMBER."
IT WAS REPORTED THAT WHILE USING BD MICROTAINER® QUIKHEEL¿ PREEMIE LANCET THERE WAS INCORRECT LABEL INFORMATION OF THREE LABELS. THREE LOT NUMBERS WERE AFFECTED. THERRE WAS NO REPORT OF PATIENT IMPACT. "WHEN THE BARCODES ON THE CASE BARCODE LABEL OF THE LOTS (CAT#368100/LOT#2259018, 2259021, 2291751) WERE READ BY KEYENCE SCANNERS, IT WAS POSSIBLE TO READ THEM, BUT THE LOT NUMBER AND THE EXPIRATION DATE WERE DETERMINED INCORRECTLY. AFTER CHECKING THE READ BARCODE INFORMATION, IT WAS CONSIDERED THAT THE BARCODE COULD NOT BE IDENTIFIED CORRECTLY BECAUSE AN ILLEGAL CHARACTER "!" OR "T" WAS ENTERED AT THE END OF THE BARCODE NUMBER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2148567 | BD MICROTAINER® QUIKHEEL¿ PREEMIE LANCET | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE | FMK | BD CARIBE LTD. | 368100 | SEE H.10 | 50382903681001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |