FDA Adverse Event
Malfunction
Summary report: N
CADD EXTENSION SET
MDR report key: 10725968
·
Received October 22, 2020
Report
- Report Number
- MW5097411
- Event Type
- Malfunction
- Date Received
- October 22, 2020
- Report Date
- October 9, 2020
- 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
PT'S MOM STATING THAT THE CADD EXTENSION SETS ARE LEAKING - PROVIDED LOT NUMBERS 3983996 AND 3983998. NO OTHER INFORMATION PROVIDED. 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? NO. DID WE 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? ONGOING? UNKNOWN, HAVE NOT HEARD ANYTHING IN ADDITION FROM THE PT. REPORTED TO (B)(6) BY PT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1180704 | CADD EXTENSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD, INC. | UNK | 3983996 | |
| 1180705 | CADD EXTENSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD, INC. | 3983998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |