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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER Back to Search Results
Device Problem Deflation Problem (1149)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/07/2024
Event Type  Injury  
Event Description
It was reported that the nurse had inflated the balloon prior to insertion and it would not deflate.After repeated manipulation with the syringe, they were finally able to deflate the balloon.While they were examining the product, the urology physician assistant approached and they showed the issue they were having.Stated that they had seen this on multiple occasions in the office.Patients come in with foleys that had been placed here at the hospital and they were unable to get the balloon deflated for removal.The pa said they believed it was happening with the foley kits they were using here, not the stand alone coude catheter that they typically use in the office.They recognized that it was not recommended to inflate the balloon to test it, but they had this issue more than once, and so the nurse did test it.Recently, they had to consult urology to remove a foley they had placed on a patient and even with cutting the balloon port, it still could not be removed.The pa eventually had to run a wire up through the port to pop the balloon, which was not an ideal scenario.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.H3 other text : device was not returned.
 
Event Description
It was reported that the nurse had inflated the balloon prior to insertion and it would not deflate.After repeated manipulation with the syringe, they were finally able to deflate the balloon.While they were examining the product, the urology physician assistant approached and they showed the issue they were having.Stated that they had seen this on multiple occasions in the office.Patients come in with foleys that had been placed here at the hospital and they were unable to get the balloon deflated for removal.The pa said they believed it was happening with the foley kits they were using here, not the stand alone coude catheter that they typically use in the office.They recognized that it was not recommended to inflate the balloon to test it, but they had this issue more than once, and so the nurse did test it.Recently, they had to consult urology to remove a foley they had placed on a patient and even with cutting the balloon port, it still could not be removed.The pa eventually had to run a wire up through the port to pop the balloon, which was not an ideal scenario.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be due to user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).The lot number is unknown; therefore, the device history record could not be reviewed.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.
 
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Brand Name
LATEX FOLEY CATHETER
Type of Device
LATEX FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18985442
MDR Text Key338677533
Report Number1018233-2024-01613
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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