MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-09-10 for VENTRICLEAR DRAINAGE CATHETER SET 50318 manufactured by Cook Inc.
[119725091]
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available. [hhs_fda_3500a_(b)(4). Pdf].
Patient Sequence No: 1, Text Type: N, H10
[119725092]
The user facility reported an issue associated with a ventriclear drainage catheter set on report (b)(4). Cook inc. Received the report notification on 17aug2018. As reported, a patient with a posterior fossa mass status post craniotomy for tumor resection underwent ventriculostomy catheter removal. During the procedure, a 3. 2 cm portion of the distal tip of the external ventricular drain fractured and was retained. The retained segment was later removed in the operating room. To date, despite several good faith attempts, additional information has not been provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02630 |
| MDR Report Key | 7861457 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-09-10 |
| Date of Report | 2019-02-13 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2018-09-10 |
| 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 | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| 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 | 2018-09-10 |
| Model Number | NA |
| Catalog Number | 50318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-10 |