MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for LONG TERM DIALYSIS CATHETER REPAIR KIT RPK-01 manufactured by Medical Components, Inc..
[75948707]
Patient Sequence No: 1, Text Type: N, H10
[75948708]
Subsequent to utilization of the catheter luer lock dual lumen dialysis catheter repair kit, the catheter was connected to the extra corporeal circuit and dialysis treatment was initiated. At this time, foam was noticed in the blood circuit originating at the hub. Multiple attempts to tighten the connection were unsuccessful. Catheter needed to be replaced. Inspection of the repaired catheter connector revealed fewer threads than the norm, the threads at a less of a pitch and also less spacing between the threads. Manufacturer response for dual lumen dialysis catheter repair kit, medcomp (per site reporter): no action taken at this time by medcomp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6590652 |
| MDR Report Key | 6590652 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-02 |
| Date of Event | 2017-03-16 |
| Report Date | 2017-05-02 |
| Date Reported to FDA | 2017-05-02 |
| Date Reported to Mfgr | 2017-05-02 |
| Date Added to Maude | 2017-05-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LONG TERM DIALYSIS CATHETER REPAIR KIT |
| Generic Name | KIT, REPAIR, CATHETER, HEMODIALYSIS |
| Product Code | NFK |
| Date Received | 2017-05-25 |
| Catalog Number | RPK-01 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL COMPONENTS, INC. |
| Manufacturer Address | 1499 DELP DRIVE HARLEYSVILLE PA 19438 US 19438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-25 |