MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC

Catalog Number 170003-000100

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

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 pediatric department reported incidents with this reference (b)(4).With sizes 80 and 100, lot# 19fe25.The catheter separated from the "y" connector.The clinical consequences are unknown at the time of logging.Additional information: there was the usual tension of a child who tries to remove his urinary catheters by himself.But we did not have such a break with other suppliers.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.No physical investigation or assessment has been conducted on the defective catheter as no actual or representative sample was returned for investigation.There was only photo provided.However, in the absence of any actual or representative sample, further investigation could not be conducted to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.

Event Description

It was reported that the pediatric department reported incidents with this reference 170003.With sizes 80 and 100, lot# 19fe25.The catheter separated from the "y" connector (see picture).The clinical consequences are unknown at the time of logging.Additional information: there was the usual tension of a child who tries to remove his urinary catheters by himself.But we did not have such a break with other suppliers.

• Brand Name: BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10905921
• MDR Text Key: 219363483
• Report Number: 8040412-2020-00234
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170003-000100
• Device Lot Number: 19FE25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1