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

Catalog Number	153622
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
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 there was no temperature displayed when using temperature sensor cable.The temperature sensor cable might have a problem.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Two temperature cables were returned without the original packaging.Gross visual evaluation: photo samples were submitted, however, could not be evaluated for the reported failure.No damage to the cord was noted during evaluation of the physical sample.Connections of the cord to the plug and socket were secure.Using a multimeter, the cords were tested for and found to have continuity.Cords were tested for and found to have continuity.Cord 1 was connected to an in-house temperature sensing catheter submerged in a water bath (119118 lot ngevz327) at 37 degrees, the cord was then attached to a kilo device and the temperature displayed reading 37 degree celsius.Unconfirmed.Cord 2 was connected to an in-house temperature sensing catheter submerged in a water bath (119118 lot ngevz327) at 37 degrees, the cord was then attached to a kilo device and the temperature displayed erratically from no reading and ranged from 32.8 c to 37c.Though the temperature displayed erratically, the sample meets the specification plug and jack must be firmly secured to wire.No actions can be taken at this time since a 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, 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 there was no temperature displayed when using temperature sensor cable.The temperature sensor cable might have a problem.

• 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: 19962657
• Report Number: 1018233-2024-04823
• Device Sequence Number: 8731960
• 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): 11/22/2024

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: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 12/02/2024
• 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