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 2015-07-14 for 100% SIL TIEMANN 2WAY 5CC 171305140 manufactured by Teleflex Medical.
[6013504]
Alleged event: the balloon burst and the catheter was found in the patient's bed with no balloon so the balloon burst inside the patient's bladder. However the nurse confirmed that the patient evacuated the balloon pieces through natural means. Sterile water 10 cc was used to inflate the balloon. A larger size catheter, size 16, was inserted in the patient. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[13769459]
(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
[25532095]
(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. There was no complaint device returned for investigation. Therefore , no physical assessment could be conducted. Burst 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 and; therefore complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[25532096]
Alleged event: the balloon burst and the catheter was found in the patient's bed with no balloon so the balloon burst inside the patient's bladder. However the nurse confirmed that the patient evacuated the balloon pieces through natural means. Sterile water 10 cc was used to inflate the balloon. A larger size catheter, size 16, was inserted in the patient. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00147 |
| MDR Report Key | 4912588 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-07-14 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-08-08 |
| Date Added to Maude | 2015-07-14 |
| 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% SIL TIEMANN 2WAY 5CC |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-07-14 |
| Catalog Number | 171305140 |
| Lot Number | 13GE31 |
| 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 | 2015-07-14 |