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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 01/05/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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 or Problem Description
It was reported that during use the catheter and tray accessories temperature was not displayed.
 
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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 Key24105494
Report Number1018233-2026-00172
Device Sequence Number16037401
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
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/05/2026
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 01/06/2026
Supplement Date Received by Manufacturer06/05/2026
Initial Report FDA Received Date01/17/2026
Supplement Report FDA Received Date06/12/2026
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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