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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 Problems Shipping Damage or Problem (1570); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Hematuria (2558)
Event Date 11/10/2022
Event Type  Injury  
Event Description
It was reported that the larger balloon had caused infections and patient had seen blood in their urine by using foley catheter.It was unknown what medical intervention was provided for infections.Per follow up via phone on (b)(6) 2022, the foley received was too big for the customer's anatomy.It was also stated that they were given foleys with 30cc balloons when they usually use foleys with 5cc balloons and did not know why liberator changed them, and it was not what their doctor prescribed them.The customer stated they had since received the correct catheters.Customer had infections while using the 30cc catheters and was given antibiotics to treat the infection.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the larger balloon had caused infections and patient had seen blood in their urine by using foley catheter.It was unknown what medical intervention was provided for infections.Per follow up via phone on (b)(6) 2022, the foley received was too big for the customer's anatomy.It was also stated that they were given foleys with 30cc balloons when they usually use foleys with 5cc balloons and did not know why liberator changed them, and it was not what their doctor prescribed them.The customer stated they had since received the correct catheters.Customer had infections while using the 30cc catheters and was given antibiotics to treat the infection.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to over gauging causing outside diameter too large and potential to cause injury to the bladder/urethra, ex: bleeding/irritation/pain.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.Correction: f,h.H11: section a through f - the information provided by bard 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 bard.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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key15879757
MDR Text Key304462850
Report Number1018233-2022-09052
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,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2022
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;
Patient SexFemale
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