UNSPECIFIED BD SECONDARY EXTENSION SET
Report
- Report Number
- 2243072-2022-01612
- Event Type
- Malfunction
- Date Received
- September 24, 2022
- Date of Event
- August 31, 2022
- Report Date
- November 2, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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.
D.4. MEDICAL DEVICE LOT #: 1023382 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #.
INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED FOR INVESTIGATION IN WHICH THE CUSTOMER HAS INDICATED THAT THEY OBSERVED LEAKAGE "THROUGH THE "Y" VALVE AT THE END OF THE TUBING." FURTHER DETAILS RELATING TO THE NATURE OF THE REPORTED ISSUE, THE CLINICAL SET UP, THE PRODUCTS IN USE, AND THE SEQUENCE OF EVENTS PRIOR TO THE REPORTED LEAKAGE OCCURRING WERE NOT PROVIDED TO AID THE INVESTIGATION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE; HOWEVER, THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE 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. H3 OTHER TEXT : SEE H10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 27-OCT-2022. H6: INVESTIGATION SUMMARY: ONE 60950E SAMPLE WAS RECEIVED FOR INVESTIGATION IN WHICH THE CUSTOMER HAS REPORTED OBSERVING LEAKAGE "THROUGH THE VALVE." RESIDUAL FLUID WAS PRESENT IN THE LINE, INCLUDING BLOOD IN THE LOWER SECTION OF TUBING. NO PACKAGING WAS PROVIDED WITH THE SAMPLE; HOWEVER, THE CUSTOMER HAS INDICATED THAT THE LOT NUMBER WAS 1023382. FURTHER INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT THE LEAKAGE WAS OBSERVED APPROXIMATELY 10 MINUTES INTO INFUSION AND THAT THE SMARTSITE HAD NOT BEEN PUNCTURED WITH A NEEDLE. EXAMINATION OF THE SAMPLE CONFIRMED THE CUSTOMER'S EXPERIENCE, AS FLUID WAS OBSERVED LEAKING FROM THE SMARTSITE. UPON CLOSER INSPECTION IT WAS NOTED THAT THERE WAS A SMALL HOLE IN THE BLUE SMARTSITE PISTON SUCH AS THAT CAUSED WHEN THE SMARTSITE IS ACCESSED WITH A SHARP OBJECT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1023382 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE; AS THE LEAKAGE WAS OBSERVED DURING INFUSION AND NOT ON PRIMING OF THE INFUSION SET IT IS UNLIKELY THAT A MANUFACTURING DEFECT CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE.
IT WAS REPORTED WHILE USING AN UNSPECIFIED BD SECONDARY EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: SOME PRODUCT HAS BEEN LEAKING THROUGH THE "Y" VALVE AT THE END OF THE TUBING.
IT WAS REPORTED WHILE USING AN UNSPECIFIED BD SECONDARY EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: SOME PRODUCT HAS BEEN LEAKING THROUGH THE "Y" VALVE AT THE END OF THE TUBING.
IT WAS REPORTED WHILE USING AN UNSPECIFIED BD SECONDARY EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: SOME PRODUCT HAS BEEN LEAKING THROUGH THE "Y" VALVE AT THE END OF THE TUBING.
IT WAS REPORTED WHILE USING AN UNSPECIFIED BD SECONDARY EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: SOME PRODUCT HAS BEEN LEAKING THROUGH THE "Y" VALVE AT THE END OF THE TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1955960 | UNSPECIFIED BD SECONDARY EXTENSION SET | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |