FDA Adverse Event
Malfunction
Summary report: N
WALKMED INFUSION 60 INCH TUBE SET WITH PRESSURE CELL AND MALE LUER LOCK
MDR report key: 6196222
·
Received December 21, 2016
Report
- Report Number
- 1723533-2016-00182
- Event Type
- Malfunction
- Date Received
- December 21, 2016
- Date of Event
- March 17, 2015
- Report Date
- March 24, 2015
- Manufacturer
- WALKMED INFUSION, LLC.
- Product Code
- FPA
- PMA / PMN Number
- K873961
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTER WAS UNABLE TO PROVIDE THE LOT NUMBER FOR THE DEVICE IN QUESTION. HOWEVER, WALKMED INFUSION HAS OBSERVED SIMILAR FAILURES. WALKMED INFUSION WAS UNABLE TO CONFIRM ANY NONCONFOMANCES WITHIN THE MANUFACTURING PROCESS AND A ROOT CAUSE HAS NOT BEEN IDENTIFIED. HOWEVER, A 100% INSPECTION OF THE PRESSURE CELL'S DIAPHRAGM WAS IMPLEMENTED IN THE MANUFACTURING PROCESS OF THIS PRODUCT.
Description of Event or Problem · 1
DURING TREATMENT, A PATIENT OBSERVED MEDICATION WAS LEAKING FROM THEIR ADMINISTRATION SET. AN INJURY WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 844678 | WALKMED INFUSION 60 INCH TUBE SET WITH PRESSURE CELL AND MALE LUER LOCK | INTRAVASCULAR ADMINISTRATION SET | FPA | WALKMED INFUSION, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |