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

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	01/23/2025
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.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 during use, the temperature display of the extension cord was unstable.
Additional Manufacturer Narrative
The reported event is confirmed.One temperature cable was 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 ip0300170, revision 7.The instructions for use were reviewed for this investigation and found to be adequate.The device history record review could not be performed without a lot number.Based on the results of the investigation, no additional actions are required at this time.Corrections: d, f, 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 during use, the temperature display of the extension cord was unstable.

• Brand Name: BARD® EXTENSION CABLE
• Common Device Name: EXTENSION CORD
• 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: 21375399
• Report Number: 1018233-2025-00870
• Device Sequence Number: 12899024
• 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): 07/23/2025

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: 02/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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