MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-12-18 for VENTRICLEAR DRAINAGE CATHETER SET N/A 50318 manufactured by Cook Inc.
[95165987]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[95165988]
The customer reported that a 0. 5 cm portion of the tip of a ventriclear drainage catheter fractured during placement of the device and was retained. The patient was operated on four days later, and the fragment was retrieved successfully. No further information is currently available. Additional information has been requested from the customer. It is unknown if the complaint device will be returned; as of the date of this report, no device has yet been received for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-04452 |
| MDR Report Key | 7126857 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-12-18 |
| Date of Report | 2018-04-04 |
| Date Mfgr Received | 2018-03-09 |
| Date Added to Maude | 2017-12-18 |
| 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 Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| 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 0R ANTIMICROBIAL AGENTS) |
| Product Code | NHC |
| Date Received | 2017-12-18 |
| Model Number | N/A |
| Catalog Number | 50318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-18 |