MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-02-02 for REPAIR KIT RPK-01 manufactured by Medcomp.
[99002371]
An investigation has been initiated. When the investigation is complete a final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[99002372]
Blood leakage at the connection between the luer and the blood tubing set. This can be counteracted by a tightening of the connection. There have been no disconnections.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518902-2018-00003 |
| MDR Report Key | 7236872 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-02-02 |
| Date of Report | 2018-07-20 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-01-04 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2018-02-02 |
| 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 | 3 |
| Brand Name | REPAIR KIT |
| Generic Name | REPAIR KIT |
| Product Code | PWR |
| Date Received | 2018-02-02 |
| Model Number | RPK-01 |
| Catalog Number | RPK-01 |
| Lot Number | MCFH990 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | 1499 DELP DRIVE HARLEYSVILLE PA 19438 US 19438 |
| Brand Name | REPAIR KIT |
| Generic Name | REPAIR KIT |
| Product Code | NFJ |
| Date Received | 2018-02-02 |
| Model Number | RPK-01 |
| Catalog Number | RPK-01 |
| Lot Number | MCFH990 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-02-02 |