BD VACUTAINER® Z BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2025-02076
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Date of Event
- October 30, 2025
- Report Date
- January 22, 2026
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 30382903676140
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D4. MEDICAL DEVICE LOT#: 5240041 D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 28-AUG-2025 INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE EVALUATION OF THE PHOTOGRAPH SHOWCASES A SHELF PACK LABEL OF THE PRODUCT. ADDITIVE ABNORMALITY COULD NOT BE SEEN IN THE PHOTO. ADDITIONALLY, 100 RETAINED SAMPLES WERE VISUALLY EXAMINED, AND NO ADDITIVE ABNORMALITIES WERE FOUND. 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 ADDITIVE ABNORMALITY. 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.
INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE EVALUATION OF THE PHOTOGRAPH SHOWCASES A SHELF PACK LABEL OF THE PRODUCT. ADDITIVE ABNORMALITY COULD NOT BE SEEN IN THE PHOTO. ADDITIONALLY, 100 RETAINED SAMPLES WERE VISUALLY EXAMINED, AND NO ADDITIVE ABNORMALITIES WERE FOUND. 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 ADDITIVE ABNORMALITY. 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.
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD VACUTAINER® Z BLOOD COLLECTION TUBES, LIQUID, ABNORMAL ADDITIVE, IS SEEN INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® Z BLOOD COLLECTION TUBES, LIQUID, ABNORMAL ADDITIVE, IS SEEN INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® Z BLOOD COLLECTION TUBES, LIQUID, ABNORMAL ADDITIVE, IS SEEN INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2463362 | BD VACUTAINER® Z BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 5240041 | 30382903676140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |