MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-09 for VENTRICLEAR DRAINAGE CATHETER SET 50318 manufactured by Cook, Inc..
[20359993]
A (b)(6) female pt underwent a procedure on (b)(6) 2013. The end ventricular drainage broke while being removed and the tip of the catheter was retained. The pt was taken to the operating room for removal of the retained catheter on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[20488699]
(b)(4). Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00400 |
| MDR Report Key | 3432858 |
| Report Source | 06 |
| Date Received | 2013-10-09 |
| Date of Report | 2013-09-09 |
| Date of Event | 2013-08-22 |
| Date Facility Aware | 2013-08-22 |
| Report Date | 2013-08-29 |
| Date Reported to Mfgr | 2013-08-29 |
| Date Mfgr Received | 2013-09-09 |
| Device Manufacturer Date | 2013-04-23 |
| Date Added to Maude | 2013-10-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| 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 | VENTRICLEAR DRAINAGE CATHETER SET |
| Generic Name | NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) |
| Product Code | NHC |
| Date Received | 2013-10-09 |
| Model Number | NA |
| Catalog Number | 50318 |
| Lot Number | F4204919 |
| ID Number | NA |
| Device Expiration Date | 2015-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 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 | 2013-10-09 |