BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS
Report
- Report Number
- 1917413-2026-00298
- Event Type
- Malfunction
- Date Received
- April 16, 2026
- Date of Event
- March 18, 2026
- Report Date
- May 26, 2026
- Manufacturer
- BECTON DICKINSON & CO (FRANKLIN LAKES)
- Product Code
- JKA
- UDI-DI
- 30382903679622
- PMA / PMN Number
- K945952
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K954592. 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: G.4. PMA / 510(K)#: K252040 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. FURTHER CLINICAL TESTING COULD NOT BE PERFORMED AS THE ERRONEOUS ANALYTE(S) WERE NOT SPECIFIED. THE SPECIFIC ANALYTES MUST BE PROVIDED IN ORDER TO PERFORM A CLINICAL ANALYSIS. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. 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 ERRONEOUS RESULTS. 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION. D4. MEDICAL DEVICE LOT#: 5269489. D4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 26-SEP-2025.
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, ERRONEOUS RESULTS WERE SEEN WITH AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, ERRONEOUS RESULTS WERE SEEN WITH AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, ERRONEOUS RESULTS WERE SEEN WITH AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500437 | BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON DICKINSON & CO (FRANKLIN LAKES) | 5269489 | 30382903679622 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |