BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
Report
- Report Number
- 2243072-2019-02191
- Event Type
- Malfunction
- Date Received
- October 3, 2019
- Date of Event
- August 6, 2019
- Report Date
- October 15, 2019
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- PMA / PMN Number
- K945952
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTION: NEW INFORMATION WAS RECEIVED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.2. DATE OF EVENT: (B)(6) 2019. B.4. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE PRODUCED A FALSE POSITIVE RESULT FOR TROPONIN AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED TO HAVE A FALSE POSITIVE RESULT FOR TROPONIN USING BD PST. THIS WAS REPORTED TO BD IN THE PAST. NO FURTHER INFORMATION WAS PROVIDED." D.1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES. D.2. MEDICAL DEVICE CATALOG#: 367960. D.3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (BROKEN BOW). D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2. MANUFACTURING LOCATION: BECTON, DICKINSON & CO. (BROKEN BOW). G.5. PMA / 510(K)#: K945952 H3 OTHER TEXT : SEE SECTION H.10.
H.6. INVESTIGATION: THE CUSTOMER DID NOT PROVIDE BD PAS WITH PRODUCT LOT NUMBER INFORMATION, WHEN REQUESTED. AFTER 3-FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, BD PAS CLOSED THIS CUSTOMER COMPLAINT. NO SAMPLE RETURNED AND DHR COULD NOT BE PERFORMED. H3 OTHER TEXT : SEE H.10
IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE PRODUCED A FALSE POSITIVE RESULT FOR TROPONIN AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED TO HAVE A FALSE POSITIVE RESULT FOR TROPONIN USING BD PST. THIS WAS REPORTED TO BD IN THE PAST. NO FURTHER INFORMATION WAS PROVIDED."
IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE PRODUCED A FALSE POSITIVE RESULT FOR TROPONIN AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED TO HAVE A FALSE POSITIVE RESULT FOR TROPONIN USING BD PST. THIS WAS REPORTED TO BD IN THE PAST. NO FURTHER INFORMATION WAS PROVIDED."
UNKNOWN MANUFACTURER: 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT THE UNSPECIFIED BD VACUTAINER® PST¿ BLOOD COLLECTION TUBE PRODUCED A FALSE POSITIVE RESULT FOR TROPONIN AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED TO HAVE A FALSE POSITIVE RESULT FOR TROPONIN USING BD PST. THIS WAS REPORTED TO BD IN THE PAST. NO FURTHER INFORMATION WAS PROVIDED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 948319 | BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |