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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER Back to Search Results
Catalog Number 33616
Device Problem Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
 
Event Description
It was reported that there was no orange part in the beginning of the foley catheter.That is, the probe was missing a piece.The probe was not used in patient, the probe was inside the original closed packaging.
 
Manufacturer Narrative
The reported event was confirmed manufacturing related.The device had not met specifications.Visual evaluation of the returned sample noted one unopened (without original packaging), silastic foley catheter.Visual inspection of the sample noted the inflation valve cap was missing from the inflation arm on the returned sample, also noted the inflation valve was observed to be positioned at an angle but fit securely in the inflation funnel, the foley catheter was inflated with 10 ml of d.I water and no issue observed.With the syringe attached the balloon deflated passively as intended.This does not meet the specifications which states "missing/incorrect components are not allowed".A potential root cause for this failure mode could be ¿machine malfunction¿.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labelling could not have prevented the reported failure.The information provided by bd represents all 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.
 
Event Description
It was reported that there was no orange part in the beginning of the foley catheter.That is, the probe was missing a piece.The probe was not used in patient, the probe was inside the original closed packaging.
 
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Brand Name
BARD® SILASTIC® FOLEY CATHETER
Type of Device
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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key17389396
MDR Text Key319918989
Report Number1018233-2023-05407
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741020063
UDI-Public(01)00801741020063
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K951103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/09/2023
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 Catalogue Number33616
Device Lot NumberNGGS4733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/30/2023
Initial Date FDA Received07/25/2023
Supplement Dates Manufacturer Received08/09/2023
Supplement Dates FDA Received08/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2022
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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