MAUDE Adverse Event Report: TELEFLEX MEDICAL 100%SILICONE 2WAY PED 3 CC

Catalog Number 170003100

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

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.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.There was no complaint device returned for investigation.Therefore , no physical assessment could be conducted and an investigation was based on document review.As part of our initiative, a simulation test was conducted with representative samples from production.No burst balloons were observed.There was no complaint device returned for investigation.Therefore , no physical assessment could be conducted and an investigation will be based on document review.

Event Description

The balloon deflated or burst.The patient's condition was reported as fine.

• Brand Name: 100%SILICONE 2WAY PED 3 CC
• 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: 6209348
• MDR Text Key: 63750986
• Report Number: 8040412-2016-00286
• 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: 12/06/2016

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: 170003100
• Device Lot Number: 16HT18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2017
• 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