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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL Back to Search Results
Catalog Number 171305-000180
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 12/17/2019
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 during use the balloon deflated and the nurse had to re-inflate on a regularly basis the balloon.The balloon was inflated with sterile water 12 ml.We have that kind of incidents with other sizes.
 
Event Description
It was reported that during use the balloon deflated and the nurse had to re-inflate on a regularly basis the balloon.The balloon was inflated with sterile water 12ml.We have that kind of incidents with other sizes.
 
Manufacturer Narrative
(b)(4).Product catalogue mentioned does not contained in the lot provided.Therefore, a dhr review could not be conducted.An actual sample was returned for investigation.Refer to the complaint description, it was likely that the balloon had a leaked.Visual examination was performed on the returned representative catheter and no material degradation or abnormalities observed.The entire components appeared to be in good condition.The sample was inflated with l0ml of air.The balloon inflated normally and after 20 minutes, the sample could stay inflate with no issue and no leak was observed.Then, the sample was deflated using an empty syringe without any problem arise.Leak balloon may happen due to several reasons such as 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 relatives' compounds.Balloon could also leak as a result of balloon had come in contact with bladder or kidney stone during use for patient with bladder or kidney stone history.In our standard operating procedure, the balloons are subjected to 100% visual inspection and any defective raw balloon will be culled out prior sent to the next process.Upon completion of assembly process , the completed assembly catheters were subjected again 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 sample was able to be inflated and deflated without any issue.No other abnormality found and sample able to perform as intended.As such, this complaint is not confirmed.
 
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Brand Name
BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key9496546
MDR Text Key177376957
Report Number8040412-2019-00375
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 12/17/2019
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 Number171305-000180
Device Lot Number10KE46
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received12/19/2019
Supplement Dates Manufacturer Received02/05/2020
Supplement Dates FDA Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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