MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 3ML PED

Catalog Number 170003-000080

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

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 balloon could not be inflated after insertion.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all products passed inspection.Two actual samples and two representative samples were returned for investigation.Based on the complaint description, it was reported that the balloon could not be inflated.Visual examination was conducted on the returned catheters and no sign of material degradation or abnormalities was observed.All the components appeared to be intact and in good condition.The samples were then inflated with 3ml of distilled water.The balloons could inflate easily, and no obstacle felt during inflation process.The samples were then deflated using an empty syringe without any issue.Attempt to re-inflate and deflate the balloon resulted with the same observation.In our current standard operating procedure, the raw balloons are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process.Based on the investigation conducted, the returned samples could inflate and deflate without any issue.No other abnormality found and samples able to perform as intended.As such, this complaint is not confirmed.

Event Description

It was reported that the balloon could not be inflated after insertion.

• Brand Name: BRILLANT 100% SIL FOLEY 3ML PED
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 8395012
• MDR Text Key: 138278180
• Report Number: 8040412-2019-00072
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• 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: 17IE37
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1