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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; UNKNOWN FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER; UNKNOWN FOLEY CATHETER Back to Search Results
Device Problems Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)
Patient Problems Injury (2348); 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.The device was not returned.
 
Event Description
It was reported that the patient experienced a mucosal membrane pressure injury on his penis during the use of a foley catheter.Complainant also stated that the catheter length was too short which doesn't allow for slack externally and was causing tension/pressure on his penis.
 
Manufacturer Narrative
The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to wrong product size selected/speed controller faulty/mix product(catheter).The device was not returned for evaluation.The lot number was unknown and the information on the date code since lot number was not available.Therefore, the device history record could not be reviewed.The labelling review was unable to review due to the unknown product code.Although the product family was unknown, the (foley catheter) ifu's are found to be adequate based on past reviews.
 
Event Description
It was reported that the patient experienced a mucosal membrane pressure injury on his penis during the use of a foley catheter.Complainant also stated that the catheter length was too short which doesn't allow for slack externally and was causing tension/pressure on his penis.
 
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Brand Name
LATEX FOLEY CATHETER
Type of Device
UNKNOWN FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10289043
MDR Text Key199983993
Report Number1018233-2020-04619
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K910846
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 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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