MAUDE Adverse Event Report: TELEFLEX MEDICAL 100%SILICONE 2WAY 5CC 12FR

Catalog Number 170605120

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The balloon deflated or burst causing leak of urine.Another catheter was inserted in the patient and there was blood in the urine.The patient's condition is unknown.

Manufacturer Narrative

(b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.There was no complaint device returned for investigation.Therefore , no physical assessment could be conducted and an investigation was based on document review.A simulation test was conducted with representative samples from production on the same catheter size and balloon volume.No issue was observed.In the absence of any actual or representative sample for investigation, we could not further investigate to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.

Event Description

The balloon deflated or burst causing leak of urine.Another catheter was inserted in the patient and there was blood in the urine.The patient's condition is unknown.

• Brand Name: 100%SILICONE 2WAY 5CC 12FR
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6209301
• MDR Text Key: 63711802
• Report Number: 8040412-2016-00284
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 170605120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1