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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 Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Pressure Sores (2326)
Event Date 04/04/2022
Event Type  Injury  
Event Description
It was reported that there has been an increase in device related hospital acquired pressure injuries.It was also stated that the foley urinary catheter was the top device for caused the most mucosal pressure injuries in march.They could address both infection risk and pressure injuries if there were not a urinary catheter.Inquirer asked to make sure that the customer had any impacts to patient related to foley statlock.Medical intervention was unknown.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urine collection.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be due to hypersensitivity to latex or bacterial infection.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the latex foley catheter product ifus were found to be adequate based on past reviews.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.The device was not returned.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned was returned for evaluation.Potential root cause for this failure mode could not be chosen due to insufficient information.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.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.
 
Event Description
It was reported that there has been an increase in device related hospital acquired pressure injuries.It was also stated that the foley urinary catheter was the top device for caused the most mucosal pressure injuries in march.They could address both infection risk and pressure injuries if there were not a urinary catheter.Inquirer asked to make sure that the customer had any impacts to patient related to foley statlock.Medical intervention was unknown.
 
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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 Key14225043
MDR Text Key290263873
Report Number1018233-2022-03079
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,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/13/2022
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) Other;
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