Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER; UNKNOWN FOLEY CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER; UNKNOWN FOLEY CATHETER Back to Search Results
Device Problems Deflation Problem (1149); Use of Device Problem (1670)
Patient Problems Fistula (1862); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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 foley catheter balloon was not deflated during the delivery caused urinary fistula and leaving the patient unable to conceive anymore children.Per follow up information received customer confirmed that the event occurred with a bard foley catheter.The customer noted that there was no malfunction in the device, rather the nurse did not deflate the balloon which resulted in a fistula from the urinary tract to the uterus and received treatment at the facility.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation and unable to determine root cause of reported problem.However, the failure mode could have been contributed by user.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 ifus were found to be adequate based on past reviews.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.H3 other text : the device was not returned.
 
Event Description
It was reported that the foley catheter balloon was not deflated during the delivery caused urinary fistula and leaving the patient unable to conceive anymore children.Per follow up information received customer confirmed that the event occurred with a bard foley catheter.The customer noted that there was no malfunction in the device, rather the nurse did not deflate the balloon which resulted in a fistula from the urinary tract to the uterus and received treatment at the facility.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10425402
MDR Text Key203502085
Report Number1018233-2020-05270
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 other,user facility
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-