MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08,distributor,forei report with the FDA on 2015-07-21 for TRANSURETHRAL CATHETER 171305-000140 manufactured by Teleflex Medical.
[6030875]
Alleged event: the indwelling catheter was cut at the level of the connection. The balloon was deflated and the catheter was removed. The report description does not clearly define if the catheter was broken or if the device was unable to be deflated and had to be cut for removal. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[13510010]
(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
[25528153]
(b)(4). The device history record for lot (14le52) was reviewed and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. Actual samples were returned for investigation and it was observed that the sample was intact and without any issues. Further examination on the actual sample using magnifying lens (10x magnification) did not reveal any sign of abrasion mark or scratch to suggest any manufacturing inadequacy. Based on our experience, it is very unlikely that the catheter could have detached without any external force or external contact. The tube was molded using injection molding machine where tube will be physically mounted in liquid silicone before it gets heated and molded inside the funnel. We did not find any problem within the product, which could have contributed from manufacturing processes. The actual returned sample was tested and complied with required standards. Therefore, we could not confirm this complaint.
Patient Sequence No: 1, Text Type: N, H10
[25528154]
Alleged event: the indwelling catheter was cut at the level of the connection. The balloon was deflated and the catheter was removed. The report description does not clearly define if the catheter was broken or if the device was unable to be deflated and had to be cut for removal. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00156 |
| MDR Report Key | 4929071 |
| Report Source | 01,05,06,08,DISTRIBUTOR,FOREI |
| Date Received | 2015-07-21 |
| Date of Report | 2015-06-23 |
| Date of Event | 2015-06-19 |
| Date Mfgr Received | 2015-08-21 |
| 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 | 2015-08-17 |
| Catalog Number | 171305-000140 |
| Lot Number | 14LE52 |
| 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 |