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 170605-000140 manufactured by Teleflex Medical.
[6436003]
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
[14243977]
Qn#(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
[25530926]
(b)(4). The device history record was reviewed and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. The returned sample was 100% visually inspected using magnification lens. The sample appeared to be in a good condition except that the balloon was split. Closer examination on the split balloon area under dino-lite revealed scratch marks near the tear region. Any defective raw balloon will be culled out before being sent to the next process. After assembly, all foley catheters are then subjected to leak test. Products that pass this test will be subjected to the next process. Based on the investigation and testing conducted on the actual sample, the split balloon could had been due to contact with sharp object such as encrustation or bladder stone that weaken the balloon membrane. Therefore, we could not confirm this complaint, as stated.
Patient Sequence No: 1, Text Type: N, H10
[25530927]
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 | 8040412-2015-00163 |
| MDR Report Key | 4929667 |
| 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 |
| Catalog Number | 170605-000140 |
| Lot Number | 14LE451 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 |