FDA Adverse Event
Malfunction
Summary report: N
MINICAP TRANSFER SET
MDR report key: 3821265
·
Received May 20, 2014
Report
- Report Number
- 1416980-2014-16247
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- March 12, 2014
- Report Date
- April 25, 2014
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- PMA / PMN Number
- K882498
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. THE EVENT WAS VERIFIED AND UPON CONCLUSION OF THE EVALUATION, THE DIRECT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE BROKEN OCCLUDER FEET. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED BUT THE EVALUATION HAS YET TO BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING EVALUATION OF THE DEVICE IT WAS OBSERVED THAT THE DEVICE HAD BROKEN OCCLUDER FEET. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300320 | MINICAP TRANSFER SET | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | DIANEAL PD4 AMBUFLEX THERAPY |