FDA Adverse Event
Malfunction
Summary report: N
LOCKING TITANIUM ADAPTER
MDR report key: 3070873
·
Received April 22, 2013
Report
- Report Number
- 1416980-2013-09994
- Event Type
- Malfunction
- Date Received
- April 22, 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). PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED TO BAXTER (B)(4) THAT WHEN THE NURSE CHANGED THE PRODUCT FOR THE PATIENT, THE TITANIUM ADAPTER COULD NOT CONNECT TO THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172603 | LOCKING TITANIUM ADAPTER | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - SWINFORD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOME CHOICE |