FDA Adverse Event
Malfunction
Summary report: N
LOCKING TITANIUM ADAPTER
MDR report key: 3072674
·
Received April 23, 2013
Report
- Report Number
- 1416980-2013-10056
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 2, 2013
- Manufacturer
- BAXTER HEALTHCARE - SWINFORD
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.
Description of Event or Problem · 1
A NURSE REPORTED THAT A TRANSFER SET HAD SPONTANESOULY DISCONNECTED FROM A TITANIUM ADAPTER DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173901 | LOCKING TITANIUM ADAPTER | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - SWINFORD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TRANSFER SET |