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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
Model Number A304416A
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the substitute foley catheters were clogging and were having to be replaced.It was stated that the staffs were thinking they were isolated incidents until they started comparing notes and realized there so many issues.The nurses had been asked to fill out safety reports on the patients that had needed their foley replaced.Also stated that one nurse alone had about 3 to replace over the last week.It was also stated that the customer was having trouble in identifying the model number and the only identifying information that the customer got from the staffs was that the image of the bag that had a different clamp than normal surestep trays.
 
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.The potential root cause for this failure could be due to blocked drainage eye/lumen or no drainage eye or user related (salt accumulation).A dhr review is not required as the lot number is unknown.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 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 the substitute foley catheters were clogging and were having to be replaced.It was stated that the staffs were thinking they were isolated incidents until they started comparing notes and realized there so many issues.The nurses had been asked to fill out safety reports on the patients that had needed their foley replaced.Also stated that one nurse alone had about 3 to replace over the last week.It was also stated that the customer was having trouble in identifying the model number and the only identifying information that the customer got from the staffs was that the image of the bag that had a different clamp than normal surestep trays.Per additional information received on (b)(6) 2021, it was reported that the foley had clogging and the patient safety reports were filed but no patient harm was reported.Customer confirmed only 3 incidents that were reported to them.They were using bard foley care kits, substitute for the surestep trays and could not identify which trays were in each department at the time of the incidents.
 
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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 30014
MDR Report Key12584837
MDR Text Key275005250
Report Number1018233-2021-06263
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741104206
UDI-Public(01)00801741104206
Combination Product (y/n)N
PMA/PMN Number
K040658
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 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA304416A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/17/2021
Initial Date FDA Received10/06/2021
Supplement Dates Manufacturer Received10/14/2021
Supplement Dates FDA Received11/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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