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

Catalog Number 170003-000080

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that: involving a (b)(6)-year-old child.After the intervention, general anesthesia - closing palatine artery, the staff noticed that the urinary catheter was pierced (hole) at the level of the hub on the proximal side.The catheter leaked; discovered after the removal of the stylet and the connection catheter - urinary collector.Another device had to be inserted.

Event Description

It was reported that: involving a 3-year-old child.After the intervention, general anesthesia closing palatine artery, the staff noticed that the urinary catheter was pierced (hole) at the level of the hub on the proximal side.The catheter leaked; discovered after the removal of the stylet and the connection catheter urinary collector.Another device had to be inserted.

Manufacturer Narrative

(b)(4).The batch card{s) for the complaint lot(s) was reviewed and all passed qa inspection.1 piece of actual sample was returned for investigation.Visual inspection was conducted on the returned sample did not reveal any obvious abnormality.When innate with 3ml of distilled water, the balloon was able to innate to its required shape and size.The innated balloon was left on work bench for 30 minutes under observation.When re-inspect again, the balloon was found partially deflated.Based on the complaint description, it was reported that there was a leak on the catheter.The entire catheter was then re-inspected again under l0x magnification revealed a hole in the shaft at proximal end approximately l0mm from the funnel which resulted to leaked for drainage lumen.Such occurrence of hole on shaft is unlikely to happen.However, we had identified this similar problem in our previous investigation.Corrective action has been taken to address this issue and documented in non-conformance report number (b)(4).The complaint is confirmed that there is evidence of hole on shaft that contributed to leaking on the sample return.

Event Description

It was reported that: involving a 3-year-old child.After the intervention, general anesthesia - closing palatine artery, the staff noticed that the urinary catheter was pierced (hole) at the level of the hub on the proximal side.The catheter leaked; discovered after the removal of the stylet and the connection catheter - urinary collector.Another device had to be inserted.

Manufacturer Narrative

(b)(4).The batch card{s) for the complaint lot(s) was reviewed and all passed qa inspection.1 piece of actual sample was returned for investigation.Visual inspection was conducted on the returned sample did not reveal any obvious abnormality.When innate with 3ml of distilled water, the balloon was able to innate to its required shape and size.The innated balloon was left on work bench for 30 minutes under observation.When re-inspect again, the balloon was found partially deflated.Based on the com plaint description, it was reported that there was a leak on the catheter.The entire catheter was then re-inspected again under l0x magnification revealed a hole in the shaft at proximal end approximately l0mm from the funnel which resulted to leaked for drainage lumen.Such occurrence of hole on shaft is unlikely to happen.However, we had identified this similar problem in our previous investigation.Corrective action has been taken to address this issue and documented in a non-conformance report.The complaint is confirmed that there is evidence of hole on shaft that contributed to leaking on the sample return.

• Brand Name: BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9304113
• MDR Text Key: 183721741
• Report Number: 8040412-2019-00308
• 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,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2019

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 Catalogue Number: 170003-000080
• Device Lot Number: 17CE13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 12/05/2019; 05/18/2020
• Supplement Dates FDA Received: 12/06/2019; 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.