BD ALARIS EXTENSION SET
Report
- Report Number
- 9616066-2024-01053
- Event Type
- Malfunction
- Date Received
- July 29, 2024
- Date of Event
- May 19, 2024
- Report Date
- September 11, 2024
- Manufacturer
- SISTEMAS MEDICOS ALARIS S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 10885403233647
- PMA / PMN Number
- K790108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT THERE WAS A LEAKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10011865 LOT NUMBER 24029420 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 14103 UNITS IN 1 LOT NUMBER WAS BUILT ON 20FEB2024. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM . IT WAS REPORTED BY CUSTOMER THAT UPON TRACING TUBING FOR DUAL SIGN NICARDIPINE RATE CHANGE, NOTICED THAT TUBING CONNECTION FROM MICROBORE TUBING TO PALL FILTER WAS LEAKING. TUBING CHANGED AND SAQ N.
NO ADDITIONAL INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 375037 | BD ALARIS EXTENSION SET | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS S.A. DE C.V. | 24029420 | 10885403233647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |