FDA Adverse Event
Malfunction
Summary report: N
UV FLASH TRANSFER SETS
MDR report key: 4133139
·
Received October 1, 2014
Report
- Report Number
- 1416980-2014-34040
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 10, 2014
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THIS IS A REPORT OF A HOME PATIENT WHO EXPERIENCED A CONNECTION ISSUE WHEN THE TRANSFER SET COULD NOT BE CONNECTED TO THE TITANIUM ADAPTER DURING PERITONEAL DIALYSIS THERAPY (DETAILS NOT PROVIDED). THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611135 | UV FLASH TRANSFER SETS | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TITANIUM ADAPTER |