MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2015-07-21 for TRANSURETHRAL CATHETER 170605 manufactured by Teleflex Medical.
[6435553]
Alleged event: the funnel was torn after a few days. Catheter was replaced. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[14244892]
(b)(4). The device sample has not been returned to the manufacturer for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[25530726]
(b)(4). The device lot number was not provided; therefore a device history record (dhr) review could not be conducted. Under visual examination, no design abnormality or material degradation were observed on the catheter. However a tear was observed at drainage funnel. Based on additional information, the failure occurred after 3 days of usage. This indicated that the product was able to perform well at the beginning. There are various reasons which could have likely contributed towards torn or broken, funnel. In current standard operating procedure, 100% visual inspection is conducted on the catheter and product is released upon passing this inspection. Based on the investigation conducted, there are various reasons that could cause the funnel to be torn and in current manufacturing process 100% visual inspection is conducted whereby defective product will be culled out. Therefore we are not able to confirm this complaint.
Patient Sequence No: 1, Text Type: N, H10
[25530727]
Alleged event: the funnel was torn after a few days. Catheter was replaced. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00153 |
| MDR Report Key | 4929266 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2015-07-21 |
| Date of Report | 2015-06-23 |
| Date of Event | 2015-06-23 |
| Date Mfgr Received | 2015-08-18 |
| Date Added to Maude | 2015-07-21 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSURETHRAL CATHETER |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-07-21 |
| Returned To Mfg | 2015-07-06 |
| Catalog Number | 170605 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-21 |