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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC Back to Search Results
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.
 
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Brand Name
BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key10992438
MDR Text Key221521511
Report Number8040412-2020-00270
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Number of Events Reported1
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 Number170003-000060
Device Lot Number19HE31
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/11/2020
Supplement Dates Manufacturer Received01/27/2021
Supplement Dates FDA Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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