MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2015-05-27 for GOLD 2WAY SIL 5CC 18FR 180705180 manufactured by Teleflex Medical.
[21092517]
Alleged event: the balloon would not deflate at time of the change. A physician had to puncture the balloon for removal. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[21514226]
Qn#: (b)(4). The device sample has not been returned to the mfr for investigation at the time of this report. The mfr will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[25531271]
(b)(4). The device history record was reviewed based on the lot and catalog number of the received representative samples and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specifications. Visual examination of the samples received did not reveal any obvious defect or abnormality. The balloons were able to be inflated without any difficulty. No foreign particles, no collapse of the lumen, or leaks occurred during functional and time lapse testing. Based on the analysis conducted, all of the returned samples are fully functional. The complaint could not be confirmed as no product dysfunction issue was detected. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8040412-2015-00101 |
| MDR Report Key | 4801671 |
| Report Source | 05,07,08 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-05-04 |
| Date of Event | 2015-05-04 |
| Date Mfgr Received | 2015-06-25 |
| Date Added to Maude | 2015-06-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE INDUSTRIAL ESTATE, KAMUNTING |
| 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 | GOLD 2WAY SIL 5CC 18FR |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-05-27 |
| Returned To Mfg | 2015-05-29 |
| Catalog Number | 180705180 |
| ID Number | 20013119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-27 |