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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 12FR
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TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 12FR Back to Search Results
Catalog Number 170605-000120
Device Problem Break (1069)
Patient Problems Pain (1994); Abdominal Cramps (2543)
Event Date 07/04/2018
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 in the last 5 days the device had to be changed 3 times, because the shaft came off the junction.No force was applied on the catheters.Thus, the catheters balloon was no longer inflated and slipped out of the abdominal wall.A change of the catheter is always painful for the patient.The bladder is now very irritated and there are severe bladder cramps.When the device came out the third time there were no available catheters in the home, so the patient had to be transported by ambulance to the urologist at the nearest hospital for device replacement.
 
Manufacturer Narrative
(b)(4).The batch card{s) for the complaint lot{s) was reviewed and passed qa inspection.No physical investigation or assessment has been conducted on the defective catheter as no actual or representative sample was returned for investigation.In the absence of any actual or representative sample, further investigation could not be conducted to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.
 
Event Description
It was reported that in the last 5 days the device had to be changed 3 times, because the shaft came off the junction.No force was applied on the catheters.Thus, the catheters balloon was no longer inflated and slipped out of the abdominal wall.A change of the catheter is always painful for the patient.The bladder is now very irritated and there are severe bladder cramps.When the device came out the third time there were no available catheters in the home, so the patient had to be transported by ambulance to the urologist at the nearest hospital for device replacement.
 
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Brand Name
BRILLANT 100% SIL FOLEY 12FR
Manufacturer (Section D)
TELEFLEX MEDICAL
perak, west malaysia
MDR Report Key7710891
MDR Text Key114937827
Report Number8040412-2018-00190
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 company representative,foreig
Type of Report Initial,Followup
Report Date 07/05/2018
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 Number170605-000120
Device Lot Number17BE08
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/05/2018
Initial Date FDA Received07/23/2018
Supplement Dates Manufacturer Received08/27/2018
Supplement Dates FDA Received08/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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