MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for MINICAP TRANSFER SET 5C4482 manufactured by Baxter Healthcare Corporation.
[184881470]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184881471]
It was reported that the twist sleeve of a minicap transfer set was broken which resulted in a leak. This was further described as? The home patient noticed betadine backing up into the transfer set even when it was capped and locked.? This occurred during an unspecified process step of peritoneal dialysis therapy. The transfer set was replaced. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01712 |
| MDR Report Key | 9878868 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-08-28 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - MOUNTAIN HOME |
| Manufacturer Street | 1900 N HIGHWAY 201 |
| Manufacturer City | MOUNTAIN HOME AR 72653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINICAP TRANSFER SET |
| Generic Name | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
| Product Code | KDJ |
| Date Received | 2020-03-25 |
| Model Number | NA |
| Catalog Number | 5C4482 |
| Lot Number | H19H28045 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |