BLOOD COLLECTION TUBES
Report
- Report Number
- MW5173496
- Event Type
- Malfunction
- Date Received
- July 29, 2025
- Date of Event
- December 1, 2023
- Report Date
- September 11, 2025
- Manufacturer
- TRI-TECH FORENSICS, INC.
- Product Code
- JKA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OK, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- N
Narratives
THE REPORTER RESPONDED TO CALL REGARDING BLOOD COLLECTION TUBES. THE REPORTER MENTIONED THREE TUBES WERE FOUND WITH PINK POWDER SUBSTANCE INSTEAD OF CLEAR WHITE SODIUM CHLORIDE POTASSIUM OXALATE (ANTI-COAGULANT) CHEMICAL IN IT. THESE TUBES ARE USED FOR TESTING BLOOD ALCOHOL LEVELS. NO ADVERSE EVENTS REPORTED. "K922342". HEALTH CODE: 4582. DEVICE CODE: 2944. REFERENCE REPORTS: MW5173494, MW5173495.
ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 9/11/2025 FOR REPORT MW5173494. REPORTER STATED HE WANTED TO INCLUDE REPORT SOURCE MANUFACTURE DATE AS SEPTEMBER 2021 AND THAT HE OBTAINED A SAMPLE TUBE FOR COMPARISON WHERE THE CHEMICALS WERE WHITE AND NOT PINK. HE ALSO STATED THIS ISSUE HAS THE POTENTIAL FOR AN ADVERSE EVENT. THE REPORTER RESPONDED TO CALL REGARDING BLOOD COLLECTION TUBES. THE REPORTER MENTIONED THREE TUBES WERE FOUND WITH PINK POWDER SUBSTANCE INSTEAD OF CLEAR WHITE SODIUM FLUORIDE POTASSIUM OXALATE (ANTI-COGULANT) CHEMICAL IN IT. THESE TUBES ARE USED FOR TESTING BLOOD ALCOHOL LEVELS. NO ADVERSE EVENTS REPORTED. "K922342". DEVICE CODE: 2944. HEALTH CODE: 4582. REFERENCE REPORTS: MW5173494, MW5173495.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1676379 | BLOOD COLLECTION TUBES | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD | JKA | TRI-TECH FORENSICS, INC. | 233948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |