MAUDE Adverse Event Report: TELEFLEX 100 SIL TIEMANN 2WAY 5CC; FOLEY CATHETER

Catalog Number 171305160

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

Alleged event: it was reported that while using urinary catheter size 16 on a coherent, non-agitated patient, the catheter came out as the balloon had deflated.The catheter had been in place for a few days before the incident.The condition of the patient is fine.

Manufacturer Narrative

The device sample has not been returned to the manufacturer will continue to monitor and trend related complaints.

• Brand Name: 100 SIL TIEMANN 2WAY 5CC
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX MEDICAL MALAYSIA
• Manufacturer Contact: effie jefferson, rn ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 4188207
• MDR Text Key: 5095499
• Report Number: 8040412-2014-00230
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 171305160
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1