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

Catalog Number	153622
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the temperature display for extension cord was sometimes possible and sometimes not possible.Stated that temperature display was failure.Per follow up information received via ibc on 26nov2024, customer confirmed that patient involvement and 2 products were affected.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Received (5) photo samples.The photo samples were submitted, however, could not be evaluated for the reported failure.Two temperature cables were returned without the original packaging.Using a multimeter, the cords were tested for and found to have continuity.Visual inspection of the sample noted set up water bath test and connected to the (in-house) generated reading matching thermometer at 36.9c when plugged directly into sensica.Using (in house) catheter and adapter, both extension cords were plugged in an attached to the kilo device and the temperature displayed erratically reading and ranged from 32.8 c to 37c.This does not meet specification per inspection procedure.No additional actions are required at this time since root cause was not identified.The device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: "labeling cannot be changed without submitting a request to the bard medical label coordinator, who will use the appropriate bard change control system and follow the required division and corporate policies and procedures.The figure on page 3 indicates the pre-printed label stock as well as the variable information.The lot number is a variable field and will be determined at the time of manufacture.The supplier shall not make any changes to the materials, form, fit, function, or manufacturing process of components covered under this component specification without receiving prior written approval from c.R.Bard.Acceptance of this specification by the supplier constitutes agreement by the supplier to produce product according to all terms of this specification." correction: d, e, h.Udi format updated with available product information per gudid.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 the temperature display for extension cord was sometimes possible and sometimes not possible.Stated that temperature display was failure.Per follow up information received via ibc on 26nov2024, customer confirmed that patient involvement and 2 products were affected.

• 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 30014 ; 7707846100
• MDR Report Key: 20912396
• Report Number: 1018233-2024-07934
• Device Sequence Number: 8466526
• Product Code: EZL
• UDI-Device Identifier: 00801741045875
• UDI-Public: (01)00801741045875
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• 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): 06/18/2025

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 Number: 153622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 06/19/2025
• 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 Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown