FDA Adverse Event
Injury
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 3854240
·
Received June 6, 2014
Report
- Report Number
- 1416980-2014-18227
- Event Type
- Injury
- Date Received
- June 6, 2014
- Report Date
- May 14, 2014
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NURSE
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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT AND OUTCOME ARE UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332941 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | DIANEAL LOW CALCIUM 1.5% AND 2.5% SOLUTIONS |