FDA Adverse Event
Malfunction
Summary report: N
CADD EXT TUBING
MDR report key: 12460295
·
Received September 10, 2021
Report
- Report Number
- MW5103845
- Event Type
- Malfunction
- Date Received
- September 10, 2021
- Report Date
- September 1, 2021
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
SPONTANEOUSLY REPORTED - PATIENT REPORTS, CADD EXT SET: LOT# 4152717 LEAKING WHERE THE FILTER IS AND THIS HAPPENED ABOUT THREE TIMES IN LAST MONTH, PATIENT BELIEVES THIS IS A BAD BATCH OF TUBING HE WAS SENT. NO ISSUES IN CONTIRUING INFUSION AFTER SWITCHING TO NEW TUBING, NO MISSED DOSES. NO OTHER INFORMATION KNOWN. REPORTED TO (B)(6) BY PT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1354804 | CADD EXT TUBING | SET, ADMINISTRATION, INTRAVASCULAR | FPA | 4152717 | |||
| 1354805 | CADD EXT TUBING | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ||||
| 1354806 | CADD EXT TUBING | SET, ADMINISTRATION, INTRAVASCULAR | FPA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |