MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL

Catalog Number 170605-000140

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the catheter shaft could be pulled out of the funnel with minimal effort.

Manufacturer Narrative

Qn#: (b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspections.1 actual sample and 4 representative samples were returned for investigation.Visual inspection showed the funnel was snapped from the shaft.Close review of the funnel section on actual sample revealed a remnant of x ray line inside the funnel lumen.Such a phenomena is likely to indicates rough or extreme force applied to the catheter which had caused shaft to snap.Such extreme tensile strength may exceed the standard requirement of the catheter strength which rendered the catheter to be detached or broke.Further test to review the funnel-shaft detachment force was conducted on the 4 representative samples via 1kg weight load test.Upon completion of the test period, all samples passed the test without funnel detached from the shafts.Nevertheless, as part of our initiative, positive released test was implemented at injection molding process.A maximum of 8 pieces of catheter from each batch were tested using weight load test during start and stop of injection molding process whereby 0.75kg (for catheter size ch6-ch10) and lkg load (for size 12ch and above) tested as per din en1616:1999 standard.This is to test the bonding strength between the funnel and tube.Batches that pass this test are subjected for release.Based on the evidence found in the investigation, the snapped catheter is likely been subjected to excessive force which caused product disfunctional.Therefore, this complaint could not be confirmed.

Event Description

It was reported that the catheter shaft could be pulled out of the funnel with minimal effort.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9717105
• MDR Text Key: 183750486
• Report Number: 8040412-2020-00066
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: 170605-000140
• Device Lot Number: 19EE21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1