MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-19 for YUEH CENTESIS CATHETER NEEDLE DTVN-4.0-20XT-10.0-YUEH manufactured by Cook, Inc..
[3057646]
The hub detached from catheter/sheath and the sheath slipped inside the patient's fluid collection. The sheath remains inside the fluid collection due to the patient being too sick at this time to remove the sheath. However, no adverse effects have been reported. No procedures have been done as of yet. They are just watching the patient.
Patient Sequence No: 1, Text Type: D, B5
[10366081]
One assembled cap/adapter and a product label were returned. The catheter shaft was not returned as it remains in the patient. The cap/adapter were examined and found to be made within specifications. Quality control verifies that the correct fittings are securely attached and that the flare is securely seated in the cap. Without return of the catheter shaft we are unable to determine what may have led to this failure. However, it is possible that the device was exposed to tensile forces beyond it's design which led to separation of the catheter shaft and allowed the catheter to migrate. We will continue to monitor for similar complaints and have notified the appropriate personnel. Per the conclusion of the risk assessment, risk mitigation action is not required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2012-00539 |
| MDR Report Key | 2895976 |
| Report Source | 06 |
| Date Received | 2012-11-19 |
| Date of Report | 2012-10-31 |
| Date of Event | 2012-10-31 |
| Date Facility Aware | 2012-10-31 |
| Report Date | 2012-10-31 |
| Date Mfgr Received | 2012-10-31 |
| Device Manufacturer Date | 2012-06-29 |
| Date Added to Maude | 2013-01-17 |
| 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 | RITA HARDEN, MANAGER |
| 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 | YUEH CENTESIS CATHETER NEEDLE |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2012-11-19 |
| Returned To Mfg | 2012-11-06 |
| Model Number | NA |
| Catalog Number | DTVN-4.0-20XT-10.0-YUEH |
| Lot Number | 3425137 |
| ID Number | NA |
| Device Expiration Date | 2015-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-11-19 |