FDA Adverse Event
Injury
Summary report: N
TRANSFER SET
MDR report key: 3180779
·
Received June 20, 2013
Report
- Report Number
- 1416980-2013-16048
- Event Type
- Injury
- Date Received
- June 20, 2013
- Date of Event
- May 18, 2013
- Report Date
- May 28, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- PMA / PMN Number
- K882498
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS, (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H12L07031 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THIS IS REPORT 3 OF 3. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. THIRTEEN DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM PERITONITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280973 | TRANSFER SET | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization | DIANEAL PD2 AMBUFLEX |