MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2015-07-21 for TRANSURETHRAL CATHETER 170605-000160 manufactured by Teleflex Medical.
[6009768]
Alleged event: the nurse inserted the catheter, when balloon was inflated, it snapped. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[14239330]
(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
[25532046]
(b)(4). The device history record for lot 14le49 was reviewed and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. Visual examination was conducted on the returned catheter and it was observed that the balloon had split. The returned sample was 100% visually inspected using magnification lens. The sample revealed scratch marks along the split area. Catheter with defective balloon will be culled out before being sent to the next process and subjected to a leak test. Catheters with defective balloon will be culled during this process. Based on the investigation conducted, split balloon would likely occur due to balloon being subjected to the sharp object which would cause the split balloon. Therefore, we could not confirm this complaint, as stated.
Patient Sequence No: 1, Text Type: N, H10
[25532047]
Alleged event: the nurse inserted the catheter, when balloon was inflated, it snapped. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00161 |
| MDR Report Key | 4929286 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-07-21 |
| Date of Report | 2015-06-25 |
| Date of Event | 2015-06-01 |
| 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 | 170605-000160 |
| Lot Number | 14LE49 |
| 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 |