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

Catalog Number 153622

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 Description

It was reported that temperatures varied up and down during measurement while using the extension cord for the temperature sensing catheter.The problem continued to occur even after replacing the cable with a new one.The monitor was nihon kohden.

Manufacturer Narrative

The reported event is unconfirmed.Photo samples were submitted, however, could not be evaluated for the reported failure.The extension cable returned without the original packaging.Gross visual evaluation: no damage to the two cords was noted.Connections of the cords to the plug and socket were secure.Using a multimeter, the cord was tested for and found to have continuity.The cord was connected to an in-house temperature sensing catheter submerged in a water bath set at 37 degrees celsius, the cord was then attached to a kilo device and the temperature displayed 37.0 degrees celsius and then stabilized at 37.1 degrees celsius, similar to the thermometer reading.The samples meet the specification "plug and jack must be firmly secured to wire.".The device history record review could not be performed without a lot number.The reported event is unconfirmed a labeling review is not required.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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that temperatures varied up and down during measurement while using the extension cord for the temperature sensing catheter.The problem continued to occur even after replacing the cable with a new one.The monitor was nihon kohden.

• Brand Name: BARD® EXTENSION CABLE
• Type of Device: EXTENSION CABLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17497912
• MDR Text Key: 320791442
• Report Number: 1018233-2023-05981
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045875
• UDI-Public: (01)00801741045875
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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 Catalogue Number: 153622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other