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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER Back to Search Results
Model Number 165816
Device Problems Material Invagination (1336); Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problems Discharge (2225); Patient Problem/Medical Problem (2688)
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 the foley mushroomed making it difficult to remove.The health professional was met with resistance when trying to remove the foley.They were able to remove the 10cc's of saline that was in the balloon, but the foley would not come out when it was pulled.The foley was cut and then was able to remove it with force.Upon removal, it was noticed that the balloon had mushroomed.The patient had a bloody discharge but no other issues were reported.
 
Event Description
It was reported that the foley mushroomed making it difficult to remove.The health professional was met with resistance when trying to remove the foley.They were able to remove the 10cc's of saline that was in the balloon, but the foley would not come out when it was pulled.The foley was cut and then was able to remove it with force.Upon removal, it was noticed that the balloon had mushroomed.The patient had a bloody discharge but no other issues were reported.
 
Manufacturer Narrative
The reported event was confirmed.Visual inspection noted only one portion of a foley catheter was received.Visual evaluation noted the balloon was mushroomed on return.This was out of specification, which stated that samples that exhibit cuffing should be rejected.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be balloon material does not shrink quickly enough.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters." h11:section a through f - 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.
 
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Brand Name
BARDEX® ALL-SILICONE FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9234348
MDR Text Key177219797
Report Number1018233-2019-06768
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741029752
UDI-Public(01)00801741029752
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 11/01/2019
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
Device Model Number165816
Device Catalogue Number165816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Initial Date Manufacturer Received 10/04/2019
Initial Date FDA Received10/24/2019
Supplement Dates Manufacturer Received10/28/2019
Supplement Dates FDA Received11/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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