MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-07-12 for RING DRAINAGE CATHETER NEEDLE SET DLPN-40-25-RING manufactured by Cook, Inc..
[3571487]
Upon introducing catheter into kidney for a nephrostomy, the white hub fell off. A wire was inserted into the catheter to exchange for a new catheter. The catheter began to break apart into small pieces upon removal (1820334-2013-00267). Fragmented pieces of catheter were retrieved from the kidney. Another cook drainage catheter was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10995980]
(b)(4). No product was returned to assist in this investigation. Without the complaint device a definitive root cause cannot be established. Based on the event description the most likely scenario is that the catheter became caught on patient anatomy. The catheter subsequently separated when the withdrawal force exceeded the design. Quality control verifies the surface of the catheter is clean and free of damage. The strength and elongation of a sample each lot of tubing are verified as well. We are unable to determine exactly what led to this failure mode. There is insufficient information to establish a root cause. We will continue to monitor for similar complaints. Per quality engineering risk assessment, there is insufficient risk to warrant risk reduction activities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00267 |
| MDR Report Key | 3231839 |
| Report Source | 07 |
| Date Received | 2013-07-12 |
| Date of Report | 2013-06-19 |
| Date of Event | 2013-06-18 |
| Date Facility Aware | 2013-06-18 |
| Report Date | 2013-06-19 |
| Date Mfgr Received | 2013-06-19 |
| Device Manufacturer Date | 2011-10-04 |
| Date Added to Maude | 2013-07-18 |
| 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 | 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 | RING DRAINAGE CATHETER NEEDLE SET |
| Product Code | DWO |
| Date Received | 2013-07-12 |
| Model Number | NA |
| Catalog Number | DLPN-40-25-RING |
| Lot Number | 2828162 |
| ID Number | NA |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 20 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 | 2013-07-12 |