BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
Report
- Report Number
- 2243072-2018-01639
- Event Type
- Malfunction
- Date Received
- November 13, 2018
- Date of Event
- October 29, 2018
- Report Date
- January 3, 2019
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- PMA / PMN Number
- BK050036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
IT WAS REPORTED THAT BD VACUTAINER SERUM BLOOD COLLECTION TUBES ARE NOT FITTING IN THE CENTRIFUGE BECAUSE OF A MOLDING DEFECT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8071863. MEDICAL DEVICE EXPIRATION DATE: 2019-07-31. DEVICE MANUFACTURE DATE: 2018-03-12. MEDICAL DEVICE LOT #: 8078553. MEDICAL DEVICE EXPIRATION DATE: 2019-08-31. DEVICE MANUFACTURE DATE: 2018-03-19. MEDICAL DEVICE LOT #: 8201561. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31. DEVICE MANUFACTURE DATE: 2018-07-20. MEDICAL DEVICE BRAND NAME: BD VACUTAINER SERUM BLOOD COLLECTION TUBE. MEDICAL DEVICE TYPE: JKA. COMMON DEVICE NAME: BLOOD COLLECTION DEVICE. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO., (BD) MEDICAL DEVICE CATALOG #: 367815. (B)(4). DEVICE AVAILABLE FOR EVAL?: YES RETURNED TO MANUFACTURER ON: 2018-11-15. MANUFACTURING LOCATION: (B)(4). DEVICE RETURN TO MANUF?: YES.
IT WAS REPORTED THAT BD VACUTAINER SERUM BLOOD COLLECTION TUBES ARE NOT FITTING IN THE CENTRIFUGE BECAUSE OF A MOLDING DEFECT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.
INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR MOLDING DEFECT WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR MOLDING DEFECT WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS CONDUCTED AND MOLDING DEFECT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 A UNSPECIFIED BD¿ BLOOD COLLECTION DEVICES ARE NOT FITTING IN THE CENTRIFUGE BECAUSE OF A MOLDING DEFECT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT A UNSPECIFIED BD¿ BLOOD COLLECTION DEVICES ARE NOT FITTING IN THE CENTRIFUGE BECAUSE OF A MOLDING DEFECT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 905305 | BD VACUTAINER® SERUM BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | SEE H.10. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |