MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-27 for RUSCH GOLD FOLEY CATHATHETER MEDICAL UNKNOWN manufactured by Teleflex Medical.
[5915937]
Alleged event: the foley catheter did not deflate after two attempts. Water came out but the balloon remained inflated. The patient's condition was reported as unk.
Patient Sequence No: 1, Text Type: D, B5
[13338340]
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
[25533188]
(b)(4). There was no complaint device returned for investigation. No catalogue number was provided. Therefore no physical assessment could be conducted. Review of current manufacturing process, all foley catheters undergoes 100% inspection, inflation, deflation and 30 minutes leak test prior to packaging. Any defective product will be culled out during this process. 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
[25533189]
Alleged event: the foley catheter did not deflate after two attempts. Water came out but the balloon remained inflated. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00123 |
| MDR Report Key | 4801693 |
| Report Source | 07 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-05-06 |
| Date of Event | 2015-05-06 |
| Date Mfgr Received | 2015-07-01 |
| 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 | 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 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 | RUSCH GOLD FOLEY CATHATHETER |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-05-27 |
| Catalog Number | MEDICAL UNKNOWN |
| ID Number | 20013234 |
| 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 MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-27 |