MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for REPAIR KIT RPK-01 manufactured by Medcomp.
[80656612]
The device involved in the incident was not returned for evaluation. The complaint information was forwarded to the engineering department for evaluation. The luer connector conforms to the current en/iso standards. Information provided stated the repair luer was used with a bard hemosplit catheter. The ifu states the device "repairs medcomp? Catheters: split cath? , hemo-flow? , hemo-flow? Xf, titan hd. Do not use to repair catheters other than those specified above. " the repair luer was used off label. First complaint of this nature.
Patient Sequence No: 1, Text Type: N, H10
[80656613]
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. The catheter needed to be replace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518902-2017-00038 |
| MDR Report Key | 6725877 |
| Date Received | 2017-07-19 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-03-16 |
| Date Mfgr Received | 2017-06-23 |
| Date Added to Maude | 2017-07-19 |
| 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 | 1499 DELP DRIVE |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal | 19438 |
| Manufacturer Phone | 2152564201 |
| Manufacturer G1 | MEDCOMP |
| Manufacturer Street | 1499 DELP DRIVE |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REPAIR KIT |
| Generic Name | REPAIR KIT |
| Product Code | NFK |
| Date Received | 2017-07-19 |
| Model Number | RPK-01 |
| Catalog Number | RPK-01 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | 1499 DELP DRIVE HARLEYSVILLE PA 19438 US 19438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-19 |