MAUDE Adverse Event Report: INMED MFG.SDN.BHD,RUSCH., TELEFLEX MEDICAL RUSCH FOELY SILICONE; FOLEY CATHETER

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

Alleged event: the catheter balloon deflated and the device fell out.The pt's condition was reported as unk.

Manufacturer Narrative

(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.

• Brand Name: RUSCH FOELY SILICONE
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): INMED MFG.SDN.BHD,RUSCH., TELEFLEX MEDICAL; p.o. box 28, kamunting; industrial estate, kamunting; perak ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; p.o. box 28,; kamunting industrial estate,; perak, west malaysia 3460 0; MY 34600
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4451366
• MDR Text Key: 5425321
• Report Number: 8040412-2015-00027
• Device Sequence Number: 1
• Product Code: BTR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1