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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; EXTENSION CORD
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® EXTENSION CABLE; EXTENSION CORD Back to Search Results
Model Number 153622
Device Problems No Display/Image (1183); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2020
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 after a few months of use with the extension cord, the patient body temperature on the monitor did not display accurately or disappeared.If a new extension cord was used, the correct body temperature was displayed.Reportedly, there was no problem with the monitor or foley catheter.The extension cord was the alleged issue.
 
Event Description
It was reported that after a few months of use with the extension cord, the patient body temperature on the monitor did not display accurately or disappeared.If a new extension cord was used, the correct body temperature was displayed.Reportedly, there was no problem with the monitor or foley catheter.The extension cord was the alleged issue.
 
Manufacturer Narrative
The reported event was unconfirmed as the device met specifications.Evaluation report of the returned sample, submitted by wonik corporation, states that when continuity tests were performed on the samples, all of them passed.The resistance values of all the samples were checked and they were below 0.7 ohm at positive and 0.3 ohm at negative.Dielectric test was performed on each sample by applying 1kv onto 6.3mm plug and 500v connecting to 3.5mm jack.It was found that there was no short circuit.A device history record review was not required per the investigation.The reported event is unrelated to labeling.Therefore, a labeling review is not required.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.
 
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Brand Name
BARD® EXTENSION CABLE
Type of Device
EXTENSION CORD
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9757134
MDR Text Key184293007
Report Number1018233-2020-01358
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741045875
UDI-Public(01)00801741045875
Combination Product (y/n)N
PMA/PMN Number
K070582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 04/02/2020
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 Number153622
Device Catalogue Number153622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Initial Date Manufacturer Received 02/04/2020
Initial Date FDA Received02/26/2020
Supplement Dates Manufacturer Received03/30/2020
Supplement Dates FDA Received04/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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