FDA Adverse Event
Malfunction
Summary report: N
MINICAP WITH POVIDONE-IODINE SOLUTION
MDR report key: 22135876
·
Received June 3, 2025
Report
- Report Number
- 8030639-2025-00009
- Event Type
- Malfunction
- Date Received
- June 3, 2025
- Date of Event
- April 29, 2025
- Report Date
- June 27, 2025
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Product Code
- KDJ
- UDI-DI
- 00085412007694
- PMA / PMN Number
- K152129
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 0
THIS REPORT IS A DUPLICATE OF MANUFACTURER REPORT NUMBER 8030639-2025-00008. ALL INFORMATION CAN BE FOUND UNDER MANUFACTURER REPORT NUMBER 8030639-2025-00008. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IODINE HAD DRIED OUT ON THE MINICAP SPONGE. THIS OCCURRED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362824 | MINICAP WITH POVIDONE-IODINE SOLUTION | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | VANTIVE US HEALTHCARE LLC | NA | M24I07B | 00085412007694 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |