FDA Adverse Event
Malfunction
Summary report: N
CADD- EXTENSION SET
MDR report key: 11228888
·
Received January 25, 2021
Report
- Report Number
- MW5098982
- Event Type
- Malfunction
- Date Received
- January 25, 2021
- Report Date
- January 13, 2021
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
CALL FROM PATIENT REGARDING CADD EXTENSION TUBING LOT 3983998, STATED THAT THE TUBING IS LEAKING FROM THE FILTER AREA. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES. DID WE [MFR] REPLACE DEVICE? YES. DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES. IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. IS THE INFUSION LIFE-SUSTAINING? YES. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124287 | CADD- EXTENSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD, INC. | 3983998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |