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

Catalog Number 170003-000060

Device Problem Burst Container or Vessel (1074)

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

Event Date 12/03/2020

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

Reported issue: balloon ruptured after inserted to the patient post-op.Pretested of balloon and catheter was done pre-operating.

Event Description

Reported issue: balloon ruptured after inserted to the patient post-op.Pretested of balloon and catheter was done pre-operating.

Manufacturer Narrative

Qn# (b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed 100% inspection.An actual sample was returned for investigation.Refer to the complaint description, it was reported that balloon ruptured after inserted to the patient post op.Pre-tested of balloon and catheter was done pre-operating.Visual examination was performed on the returned sample and no material degradation or abnormalities observed.The entire components appeared to be in good condition.The returned sample then inflate with 1.5m1 of distilled water.The balloons inflated normally and no difficulties during inflation.The sample then deflated using and empty syringe without any problem arise.Burst balloon may happen due to several reasons such as in contact with sharp object during use i.E.Contact with clamper, kidney dish/tray , overinflating or contact with contradict lubricants such as oil based antiseptic phenols or their derivatives, grease, petroleum jelly , petroleum spirit, paraffin or other relative compounds.Balloon could also leak because of balloon had encounter bladder or kidney stone during use for patient with bladder or kidney stone history.In current standard operating procedure as per spm-as1-003, 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, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test (spma52- 004).Catheter with defective balloon will be culled out.There were no abnormalities or design irregularities observed on the returned sample.The sample also can be inflated and deflated with no issue.Therefore, this complaint could not be confirmed as stated.

• Brand Name: BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10992438
• MDR Text Key: 221521511
• Report Number: 8040412-2020-00270
• 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: 12/08/2020

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 Catalogue Number: 170003-000060
• Device Lot Number: 19HE31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1