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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; SILICONE FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; SILICONE FOLEY CATHETER Back to Search Results
Device Problems Deflation Problem (1149); Material Invagination (1336); Difficult to Remove (1528); Structural Problem (2506); Physical Resistance/Sticking (4012)
Patient Problem Discomfort (2330)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that while deflating the catheter balloon, the balloon seemed to fold over onto itself, causing a raised ridge.The complainant reported that it always felt like there was a lot of resistance and patient discomfort with the catheter removal.The complainant reportedly had to pull hard and force the catheter out.No medical intervention was reported.
 
Manufacturer Narrative
The reported event was confirmed as cause unknown.Visual evaluation of the photo sample noted a ridge on the balloon of the catheter.Ridges are out of specification per the standard, which states balloons must not be stretched, wrinkled, or deformed.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be incorrect trimming process.The lot number is unknown therefore the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that while deflating the catheter balloon, the balloon seemed to fold over onto itself, causing a raised ridge.The complainant reported that it always felt like there was a lot of resistance and patient discomfort with the catheter removal.The complainant reportedly had to pull hard and force the catheter out.No medical intervention was reported.
 
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Brand Name
ALL SILICONE CATHETER
Type of Device
SILICONE FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8982616
MDR Text Key157457302
Report Number1018233-2019-05489
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 10/01/2019
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2019
Initial Date Manufacturer Received 08/22/2019
Initial Date FDA Received09/10/2019
Supplement Dates Manufacturer Received09/25/2019
Supplement Dates FDA Received10/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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