BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Report
- Report Number
- 1024879-2023-00138
- Event Type
- Malfunction
- Date Received
- March 13, 2023
- Date of Event
- February 22, 2023
- Report Date
- June 8, 2023
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903673426
- PMA / PMN Number
- K030573
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2144654. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2022-05-24. MEDICAL DEVICE LOT #: 0252273. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2020-09-08. MEDICAL DEVICE LOT #: 2144654. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2022-05-24. . MEDICAL DEVICE LOT #: 0252273. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2020-09-08. 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: D9: DEVICE AVAILABLE FOR EVALUATION: YES D9: RETURNED TO MANUFACTURER ON: 2023-04-04 H.6. INVESTIGATION SUMMARY: BD RECEIVED [2] SAMPLES FROM LOT 0252273 AND [3] PHOTOS FOR INVESTIGATION. TWO OF THE 3 CUSTOMER PHOTOS SHOW PRODUCT WITH LOT NUMBER 0252273 INSIDE OF A SHELF CARTON LABELLED LOT 2144654. THE PHOTO ALSO SHOWS THAT LOT NUMBER 0252273 IS EXPIRED. HOWEVER, BD MAKES NO CLAIMS ON EXPIRED PRODUCTS. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED BASED ON THE CUSTOMER PHOTO PROVIDED. BD IS ABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE MODE OF INCORRECT PACKAGING FOR LOT 0252273 AND LOT 2144654 BASED ON CUSTOMER PHOTO ANALYSIS. BD IS ABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE MODE OF EXPIRED FOR LOT 0252273 BASED ON CUSTOMER PHOTO ANALYSIS. ADDITIONALLY, THE 2 CUSTOMER SAMPLES FROM LOT 0252273 WERE VISUALLY INSPECTED FOR INCORRECT PACKAGING. BOTH SAMPLES PASSED AS THE TOP WEB LABELLING WAS CORRECT. THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED FOR INCORRECT PACKAGING BASED ON CUSTOMER SAMPLE TESTING RESULTS. BD IS UNABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE MODE OF INCORRECT PACKAGING FOR LOT 0252273 BASED ON CUSTOMER SAMPLE TESTING ANALYSIS. IN ADDITION, THE 2 CUSTOMER SAMPLES WERE INSPECTED FOR EXPIRED PRODUCT. THE PRODUCT WAS EXPIRED, BUT BD MAKES NO CLAIMS ON EXPIRED PRODUCT. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED FOR EXPIRED BASED ON CUSTOMER SAMPLE TESTING ANALYSIS. BD IS ABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE MODE OF EXPIRED FOR LOT 0252273 BASED ON CUSTOMER SAMPLE TESTING ANALYSIS. ADDITIONALLY, 100 RETAIN SAMPLES FROM LOT 0252273 WERE INSPECTED FOR CORRECT INFORMATION ON THE BLISTER PACKS AND CORRECT INFORMATION ON SHELF CARTON. ALL SAMPLES PASSED TESTING EXHIBITING CORRECT INFORMATION ON BOTH PACKAGES. THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED FOR INCORRECT PACKAGING BASED ON RETAIN SAMPLE TESTING RESULTS. BD IS UNABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE MODE OF INCORRECT PACKAGING FOR LOT 0252273 BASED ON RETAIN SAMPLE TESTING ANALYSIS. IN ADDITION, 100 RETAIN SAMPLES FROM LOT 2144654 WERE INSPECTED FOR CORRECT INFORMATION ON THE BLISTER PACKS AND CORRECT INFORMATION ON SHELF CARTON. ALL SAMPLES PASSED TESTING EXHIBITING CORRECT INFORMATION ON BOTH PACKAGES. THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED FOR INCORRECT PACKAGING BASED ON RETAIN SAMPLE TESTING RESULTS. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS AN INCORRECT EXPIRATION DATE (INCORRECT EXPIRATION DATE ON PRODUCT BEYOND SPECIFIED SHELF LIFE). THIS EVENT AFFECTED 40 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE VACUTAINER PUSH BUTTON'S SERIAL NUMBER AND EXPIRATION DATE DON'T MATCH WITH THE PACKAGE, AND THE PRODUCT HAS EXPIRED."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS AN INCORRECT EXPIRATION DATE (INCORRECT EXPIRATION DATE ON PRODUCT BEYOND SPECIFIED SHELF LIFE). THIS EVENT AFFECTED 40 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE VACUTAINER PUSH BUTTON'S SERIAL NUMBER AND EXPIRATION DATE DON'T MATCH WITH THE PACKAGE, AND THE PRODUCT HAS EXPIRED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594078 | BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 367342 | SEE H.10 | 50382903673426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |