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 170605-000120 manufactured by Teleflex Medical.
[16955940]
Alleged event: the head nurse from the rehabilitation unit reported that the catheter was leaking. The measure taken by the nurse was to reinflate the catheter with 8 cc. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[17166092]
(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
[25530809]
(b)(4). The device history record for lot (13dt29) was reviewed and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. No alleged defective product or representative sample was returned for investigation purposes. The catheter leak could be due to various reasons. However, in the absence of the complaint sample, further investigation could not be conducted and the actual root cause of this phenomenon could not be determined. Therefore, this complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[25530810]
Alleged event: the head nurse from the rehabilitation unit reported that the catheter was leaking. The measure taken by the nurse was to reinflate the catheter with 8 cc. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00155 |
| MDR Report Key | 4929132 |
| Report Source | 01,05,06,08,DISTRIBUTOR,FOREI |
| Date Received | 2015-07-21 |
| Date of Report | 2015-06-23 |
| Date of Event | 2015-06-12 |
| 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 |
| Catalog Number | 170605-000120 |
| Lot Number | 13DT29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |