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

Model Number IPN050136

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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 burst.No parts of the balloon were left in the patient.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.6 pieces of representative samples were returned for investigation.(state the evaluation, testing and based on the complaint description , it was reported that balloon is findings on the returned sample.) burst.Inspection was carried out on the representative samples by inflating the catheter with l0mm of water and it was observed that the balloon can be inflated and deflated without any issue.There was no abnormalities or design irregularities observed on the returned representative samples.The representative samples were then subjected to 14 days soak test to observe any burst balloon.However, the samples are still under soak test period, hence this report will be revised once the soak test end.Based on current production samples soak test result, there was no balloon burst found along the soak period.In current standard operating procedure, according to spm-asl-003 the products 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, as per spm-a52-004 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.There was no abnormalities or design irregularities observed on the returned representative samples.The samples also can be inflated and deflated with no issue.For further investigation, the samples were subjected to 14 days soak test.Based on current production samples soak test result, there was no balloon burst found along the soak period.Therefore, this complaint could not be confirmed as stated.

Event Description

It was reported that the balloon burst.No parts of the balloon were left in the patient.

Event Description

It was reported that the balloon burst.No parts of the balloon were left in the patient.

Manufacturer Narrative

Qn#(b)(4).6 pieces of rep representative samples were returned for investigation.Based on the complaint description, it was reported that balloon is burst.Inspection was carried out on the representative samples by inflating the catheter with 10ml of water and it was observed that the balloon can be inflated and deflated without any issue.There was no abnormalities or design irregularities observed on the returned representative samples.The representative samples were then subjected to 14 days soak test to observe any burst balloon.However, there was no sign of balloon deflation or balloon burst found along the soaked period.In current standard operating procedure, according to spm-asl-003 the products 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, as per spm-a52-004 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.There was no abnormalities or design irregularities observed on the returned representative samples.The samples also can be inflated and deflated with no issue.For further investigation, the sample was subjected to 14 days soak test.However , there was no sign of balloon deflation or balloon burst found along the soak period.Therefore, this complaint could not be confirmed as stated.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10748750
• MDR Text Key: 214803553
• Report Number: 8040412-2020-00218
• 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,Followup
• Report Date: 10/08/2020

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 Model Number: IPN050136
• Device Catalogue Number: 170605-000140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/20/2020; 12/08/2020
• Supplement Dates FDA Received: 11/20/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1