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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 170003-000080
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2020
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
It was reported that: happened in the surgery department for children.The doctor noticed that the catheter broke at the level of the y junction.Between the proximal side of the y and the tubing of the catheter.Clinical consequences unknown at logging.
 
Event Description
It was reported that: happened in the surgery department for children.The doctor noticed that the catheter broke at the level of the y junction.Between the proximal side of the y and the tubing of the catheter.Clinical consequences unknown at logging.
 
Manufacturer Narrative
(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inpection.There is one actual sample returned for investigation.Based on complaint description it was stated that the catheter had broken at the funnel joint and the shaft.From a physical review on the sample return, there is no abnormality aside to broken area between the funnel and the shaft for the actual sample returned for investigation.The sample was subjected to magnification at 50x using dino-lite magnifying tools.It was determining the remnant of the shaft still intact in the funnel area.The end shaft where the broken occur present a jagged surface which suggesting there is either excess torsion or tensile force had been applied resulting the detachment of both.Catheter broke may occur due to various reasons such as catheter was in contact with sharp or pointed object, effect of clamper used, excessive force applied at the funnel end or between the shaft as a result of catheter stuck at crib rail or tube extended as the patient glide on the bed.Lt is also common for the patient to pull the catheter out of their bladder due to discomfort.Such extreme tensile or torsion strength may exceed the standard requirement of catheter strength and render the catheter to be detached or broke.Nevertheless, as part of our initiative, positive released test was conducted at injection molding process.As per spm-as1-002, maximum of 8 pieces of catheter from each batch were tested using weight load during start and stop of injection molding process.0.75kg load (for catheter size ch6-ch10) and 1kg load (for size ch12 and above) will be tested as per bs en 15020596:2018 standard.This is to test the bonding strength between the funnel and tube.Batches that pass this test are subject for release.It was observed the remnant of the shaft was present inside the funnel suggesting there is not a mechanical failure joint on the assembly.The jagged surface on the shaft end suggesting there is an external torsion or tensile that perhaps exceed the product maximum tensile force allowable per standard requirement.Therefore, this complaint could not be confirmed.
 
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Brand Name
BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key11022417
MDR Text Key222636590
Report Number8040412-2020-00273
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 12/15/2020
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 Number170003-000080
Device Lot NumberKME20G0163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2020
Initial Date Manufacturer Received 12/15/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received02/03/2021
Supplement Dates FDA Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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