BD CHECK VALVE,MALE/FEMALE LUER LOCK
Report
- Report Number
- 2243072-2021-02830
- Event Type
- Malfunction
- Date Received
- November 24, 2021
- Date of Event
- October 27, 2021
- Report Date
- August 2, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF THE COMPLAINT IN WHICH THE CUSTOMER HAS REPORTED OBSERVING BACK FLOW OF BLOOD, WHEN USING 04302243317 PRODUCTS FROM LOT 1020447. FURTHER DETAILS RELATING TO THE CLINICAL SET UP, AND SEQUENCE OF EVENTS PRIOR TO THE BACK FLOW OCCURRING WERE NOT AVAILABLE TO ASSIST THE INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED IN THIS INSTANCE AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1020447 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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.
CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2243072-2021-02830 WAS SENT IN ERROR. MFR REPORT# 2243072-2021-02830 IS VOID AS A RESULT.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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.
IT WAS REPORTED THAT BD CHECK VALVE,MALE/FEMALE LUER LOCK HAD BLOOD BACKFLOW DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE VALVE DOES NOT WORK, BLOOD FLOWS THROUGH"
IT WAS REPORTED THAT BD CHECK VALVE, MALE/FEMALE LUER LOCK HAD BLOOD BACKFLOW DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE VALVE DOES NOT WORK, BLOOD FLOWS THROUGH".
IT WAS REPORTED THAT BD CHECK VALVE,MALE/FEMALE LUER LOCK HAD BLOOD BACKFLOW DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE VALVE DOES NOT WORK, BLOOD FLOWS THROUGH."
IT WAS REPORTED THAT BD CHECK VALVE, MALE/FEMALE LUER LOCK HAD BLOOD BACKFLOW DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE VALVE DOES NOT WORK, BLOOD FLOWS THROUGH".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1768718 | BD CHECK VALVE,MALE/FEMALE LUER LOCK | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON | 1020447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |