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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL 100%SILICONE 2WAY 5CC 16FR; FOLEY CATHETER
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TELEFLEX MEDICAL 100%SILICONE 2WAY 5CC 16FR; FOLEY CATHETER Back to Search Results
Catalog Number 170605160
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2015
Event Type  malfunction  
Event Description
Alleged event: after the catheter was inserted in the surgery theatre, the female patient lost the catheter a few days later while walking.The balloon split.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The device sample has not been returned for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.
 
Manufacturer Narrative
(b)(4).The device lot number was not provided; therefore, a device history record (dhr) review could not be conducted.The returned sample appeared to be in a good condition except that the balloon was split.Closer examination on the split balloon area under dino-lite revealed scratch mark near the tear region.In our standard operating procedure the raw balloons are subjected to 100% visual inspection.Defective raw balloon will be culled out before sent to the next process.All foley catheters are subjected to leak test.Products that pass this test will be subjected to the next process.Based on the investigation and testing conducted on the actual sample, it is believed that the scratch mark found near the split area had initiated the tear.Therefore, we could not confirm this complaint as stated.No conclusion code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.
 
Event Description
Alleged event: after the catheter was inserted in the surgery theatre, the female patient lost the catheter a few days later while walking.The balloon split.The patient's condition was reported as fine.
 
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Brand Name
100%SILICONE 2WAY 5CC 16FR
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
TELEFLEX MEDICAL
perak, west malaysia
Manufacturer (Section G)
TELEFLEX MEDICAL
po box 28, kamunting industrial estate
perak, west malaysia 3460 0
MY   34600
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key4913265
MDR Text Key6437250
Report Number8040412-2015-00154
Device Sequence Number1
Product Code FGH
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number170605160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
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