MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2015-05-27 for RUSCH 6FR FOLEY CATHETER MEDICAL UNKNOWN manufactured by Teleflex Medical.
[5926580]
Alleged event: the catheter balloon ruptured when inflated after placement into the patient and the catheter slipped out. The patient's condition was reported as unk.
Patient Sequence No: 1, Text Type: D, B5
[13280979]
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
[22554003]
Qn#(b)(4). In the absence of product catalogue and lot number, document review could not be performed to observe any abnormalities in the manufacturing process. One actual sample was returned for investigation. Returned sample was removed carefully from polybag. Visual examination on the catheter did not show any obvious defect, material degradation or damage. Attempt to inflate the balloon with 1. Sml air was successful. The balloon was able to be inflated to its required size and shape without any failure. No leakage or balloon rupture observed. In our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process. Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test. Catheter with defective balloon will be culled out during this process. Based on the investigation conducted on the returned sample, the balloon was able to be inflated without any failure. Therefore this complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[22554004]
Alleged event: the catheter balloon ruptured when inflated after placement into the patient and the catheter slipped out. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00124 |
| MDR Report Key | 4801695 |
| Report Source | 01,06,08 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-05-07 |
| Date of Event | 2015-05-05 |
| Date Mfgr Received | 2015-07-06 |
| Date Added to Maude | 2015-06-23 |
| 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 6FR FOLEY CATHETER |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-05-27 |
| Returned To Mfg | 2015-06-02 |
| Catalog Number | MEDICAL UNKNOWN |
| ID Number | 20013230. |
| Device Availability | R |
| 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 MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-27 |