MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-08-26 for VENTRICLEAR DRAINAGE CATHETER SET N/A 50318 manufactured by Cook Inc.
[24069207]
Lot number not provided by the reporter. Expiration date unknown as lot number is unknown. Udi #: unknown as lot is unknown. (b)(4). Event is still under investigation. Corrected data from user facility: date of report: 08/03/2015. Brand name: ventriclear drainage catheter set. Common device name: nhc catheter, ventricular (containing antibiotic or antimicrobial agents). Date user facility or importer became aware: 06/18/2015. Date of this report: 06/xx/2015. Date report sent to fda: 06/xx/2015.
Patient Sequence No: 1, Text Type: N, H10
[24069208]
From voluntary medwatch report provided by another manufacturer: attempted removal of an external ventricular drain (evd), met with resistance, and on third attempt made by different surgeon while applying pressure, evd snapped. Patient taken to or for removal of remaining of drain. No sequalee. Patient discharged home next day. "
Patient Sequence No: 1, Text Type: D, B5
[35324083]
Lot number not provided by the reporter. Expiration date unknown as lot number is unknown. Udi #: unknown as lot is unknown. (b)(4). Corrected data from user facility: ventricular drainage catheter set. Nhc catheter, ventricular (containing antibiotic or antimicrobial agents) investigation / evaluation: no product was returned; however, a review of the complaint history, device history record, instructions for use (ifu) and quality control (qc) was conducted during the course of investigation. Per quality control specification, there is a confirmation that the surface of the catheter is free of damage, dirt and foreign debris. This product is shipped with an instructions for use (ifu); which states contraindications, warnings, precautions and instructions for use. Based on the information provided, the catheter met resistance upon removal from the patient. It is possible that the catheter was exposed to forces beyond its design. The appropriate internal personnel have been notified and we will continue to monitor for similar complaints. Per the quality engineering risk assessment (qera); no further risk reduction is required.
Patient Sequence No: 1, Text Type: N, H10
[35324084]
From voluntary medwatch report provided by another manufacturer: attempted removal of an external ventricular drain (evd), met with resistance, and on third attempt made by different surgeon while applying pressure, the evd snapped. The patient taken to or for removal of remaining drain. No sequalee. Patient discharged home next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2015-00534 |
| MDR Report Key | 5031138 |
| Report Source | OTHER |
| Date Received | 2015-08-26 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-06-18 |
| Date Facility Aware | 2015-06-18 |
| Date Mfgr Received | 2015-08-07 |
| Date Added to Maude | 2015-08-26 |
| 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 |
| 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 | 2015-08-26 |
| Model Number | N/A |
| Catalog Number | 50318 |
| ID Number | N/A |
| 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 | 2015-08-26 |