FDA Adverse Event
Malfunction
Summary report: N
LOCKING TITANIUM ADAPTER
MDR report key: 3072739
·
Received April 23, 2013
Report
- Report Number
- 1416980-2013-10060
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 26, 2013
- Report Date
- April 1, 2013
- Manufacturer
- BAXTER HEALTHCARE - SWINFORD
- Product Code
- KDJ
- PMA / PMN Number
- K894783
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS COMPLAINT HAD NO SAMPLE OR BATCH DETAILS AVAILABLE. IT WASN'T POSSIBLE TO PERFORM A BATCH FILE OR COMPLAINT FILE REVIEW AS NO BATCH NUMBER WAS PROVIDED. NO TRENDS WERE IDENTIFIED FOR THIS COMPLAINT.
Description of Event or Problem · 1
A NURSE REPORTED A CONNECTION ISSUE ASSOCIATED WITH A TITANIUM ADAPTER USED FOR PERITONEAL DIALYSIS THERAPY. IT WAS REPORTED THAT THE TITANIUM ADAPTER WOULD NOT CONNECT TO THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS IS REPORT 2 OF 2 INVOLVED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174727 | LOCKING TITANIUM ADAPTER | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - SWINFORD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TRANSFER SET |