BD VACUTAINER® SST¿
Report
- Report Number
- 1024879-2025-01056
- Event Type
- Malfunction
- Date Received
- July 29, 2025
- Date of Event
- July 10, 2025
- Report Date
- September 11, 2025
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 30382903679882
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES DO NOT SUCTION PROPERLY. ADDITIONALLY, IT IS DIFFICULT TO PIERCE THE STOPPER OF AN UNSPECIFIED NUMBER OF TUBES AND RESULTS IN A BENT NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. D4. MEDICAL DEVICE LOT#: 5093392. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2026. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 03-APR-2025. IMDRF ANNEX A GRID: A140303 - SHORT FILL (1575) & A150206 - DIFFICULT TO INSERT (1316).
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 28-JUL-2025. INVESTIGATION SUMMARY BD RECEIVED 70 SAMPLES FOR INVESTIGATION. OUT OF THESE, 20 SAMPLES UNDERWENT FUNCTIONAL TESTS, AND ALL TUBES WERE WITHIN SPECIFICATION. ADDITIONALLY, 20 RETAINED SAMPLES WERE ALSO SUBJECTED TO FUNCTIONAL TESTS, AND ALL THESE TUBES WERE ALSO WITHIN SPECIFICATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODES: DEFECTIVE STOPPER MOLDING AND UNDERFILL. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K230855. 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® SST¿, AN UNSPECIFIED NUMBER OF TUBES DO NOT SUCTION PROPERLY. ADDITIONALLY, IT IS DIFFICULT TO PIERCE THE STOPPER OF AN UNSPECIFIED NUMBER OF TUBES AND RESULTS IN A BENT NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES DO NOT SUCTION PROPERLY. ADDITIONALLY, IT IS DIFFICULT TO PIERCE THE STOPPER OF AN UNSPECIFIED NUMBER OF TUBES AND RESULTS IN A BENT NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, THE CAPS ARE POPPING OFF 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 |
|---|---|---|---|---|---|---|---|
| 1096713 | BD VACUTAINER® SST¿ | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 5093392 | 30382903679882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |