MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-06-17 for COOK TPN DOUBLE LUMEN CATHETER REPAIR SET C-RHCD-7.0 manufactured by Cook, Inc..
[21658633]
Reference uf report # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21910849]
(b)(4). Corrected data from use facility report that was received on (b)(4) 2013. Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00243 |
| MDR Report Key | 3198464 |
| Report Source | 00 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-05-20 |
| Date of Event | 2013-05-02 |
| Date Facility Aware | 2013-05-02 |
| Report Date | 2013-05-20 |
| Date Mfgr Received | 2013-05-21 |
| Device Manufacturer Date | 2013-03-08 |
| Date Added to Maude | 2013-07-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY P.O. BOX 489 |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK TPN DOUBLE LUMEN CATHETER REPAIR SET |
| Product Code | NFK |
| Date Received | 2013-06-17 |
| Model Number | NA |
| Catalog Number | C-RHCD-7.0 |
| Lot Number | 4096196 |
| ID Number | NA |
| Device Expiration Date | 2014-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-17 |