EXT STABILIZED EXTENSION SET MAXZERO
Report
- Report Number
- 2243072-2023-00189
- Event Type
- Malfunction
- Date Received
- February 12, 2023
- Date of Event
- January 18, 2023
- Report Date
- May 19, 2023
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE END OF THE EXT STABILIZED EXTENSION SET MAXZERO HAD A LOOSE CONNECTION TO THE NEEDLE-FREE CONNECTOR AND DETACHED FROM IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER WAS CONCERNED THAT THE END OF THE EXT EXTENSION SET (WHERE THE NEEDLE FREE CONNECTOR IS ATTACHED) CAN BE RIPPED OFF EASILY." MEDICAL DEVICE BRAND NAME: EXT STABILIZED EXTENSION SET MAXZERO CATALOG # 201-0021 MEDICAL DEVICE LOT #: 9451923. MEDICAL DEVICE EXPIRATION DATE: 29-MAR-2025. DEVICE MANUFACTURE DATE: 01-JUL-2022 .
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 FRANKLIN LAKES, NJ HAS BEEN LISTED. AND THE FRANKLIN LAKES 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.
H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED THE EXTENSION TUBING DETACHED FROM THE MAIN HUB OF THE DEVICE. THE REPORTED ISSUE WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED. AT THIS TIME, A ROOT CAUSE COULD NOT BE DETERMINED EXACTLY WHERE IN THE MANUFACTURING PROCESS THIS OCCURRED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
IT WAS REPORTED THAT THE END OF THE EXT STABILIZED EXTENSION SET MAXZERO HAD A LOOSE CONNECTION TO THE NEEDLE-FREE CONNECTOR AND DETACHED FROM IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER WAS CONCERNED THAT THE END OF THE EXT EXTENSION SET (WHERE THE NEEDLE FREE CONNECTOR IS ATTACHED) CAN BE RIPPED OFF EASILY."
IT WAS REPORTED THAT THE END OF THE UNSPECIFIED BD¿ EXT EXTENSION SET HAD A LOOSE CONNECTION TO THE NEEDLE-FREE CONNECTOR AND DETACHED FROM IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER WAS CONCERNED THAT THE END OF THE EXT EXTENSION SET (WHERE THE NEEDLE FREE CONNECTOR IS ATTACHED) CAN BE RIPPED OFF EASILY."
IT WAS REPORTED THAT THE END OF THE EXT STABILIZED EXTENSION SET MAXZERO HAD A LOOSE CONNECTION TO THE NEEDLE-FREE CONNECTOR AND DETACHED FROM IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER WAS CONCERNED THAT THE END OF THE EXT EXTENSION SET (WHERE THE NEEDLE FREE CONNECTOR IS ATTACHED) CAN BE RIPPED OFF EASILY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1816014 | EXT STABILIZED EXTENSION SET MAXZERO | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON | 9451923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |