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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® EXTENSION CABLE

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C.R. BARD INC. (COVINGTON) -1018233 BARD® EXTENSION CABLE Back to Search Results
Catalog Number 153622
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/17/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that there was no temperature display in the temperature sensing foley catheter, or sometimes there was, but a low value was displayed.
 
Additional Manufacturer Narrative
Initial reporter name: (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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.
 
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Brand Name
BARD® EXTENSION CABLE
Common Device Name
EXTENSION CABLE
Manufacturer (Section D)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key24445551
Report Number1018233-2026-01242
Device Sequence Number10301047
Product Code EZL
UDI-Device Identifier00801741045875
UDI-Public(01)00801741045875
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K070582
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Other,User Facility
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/16/2026
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
Operator of Device Health Professional
Device Catalogue Number153622
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/17/2026
Supplement Date Received by Manufacturer06/16/2026
Initial Report FDA Received Date02/25/2026
Supplement Report FDA Received Date06/25/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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