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 2015-07-08 for 100%SILICONE 2WAY 5CC 18F 170605 - 000180 manufactured by Teleflex Medical.
[6067587]
Alleged event: the balloon deflated and the catheter came out of the patient. A new catheter was inserted. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[14248862]
(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
[25531506]
(b)(4). The device lot number was not provided; therefore, a dhr review could not be conducted. There was no complaint device returned for investigation; therefore, no physical assessment could be conducted. Leak balloon could be due to various reasons. However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted. Therefore this complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[25531507]
Alleged event: the balloon deflated and the catheter came out of the patient. A new catheter was inserted. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00140 |
| MDR Report Key | 4899034 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-07-08 |
| Date of Report | 2015-06-09 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-08-07 |
| Date Added to Maude | 2015-07-08 |
| 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 | 100%SILICONE 2WAY 5CC 18F |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-07-08 |
| Catalog Number | 170605 - 000180 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-07-08 |