MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH 6FR FOLEY CATHETER

Catalog Number MEDICAL UNKNOWN

Device Problem Inflation Problem (1310)

Patient Problem No Information (3190)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: RUSCH 6FR FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; industrial estate, kamunting; perak, west malaysia 3460 0; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4801695
• MDR Text Key: 5926580
• Report Number: 8040412-2015-00124
• Device Sequence Number: 1
• Product Code: FGH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: MEDICAL UNKNOWN
• Other Device ID Number: 20013230.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1