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

Model Number 153622

Device Problems Fitting Problem (2183); Component Misassembled (4004)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was reported that the temperature display was incorrect while using the extension cord for temperature sensing foley catheter.There was poor meshing of catheter and cable.

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.

Manufacturer Narrative

The reported event is unconfirmed as the reported failure could not be reproduced.Photo samples were submitted, however, could not be evaluated for the reported failure.Two extension cables were returned without the original packaging.The cables were labeled 1 - 2 for identification purposes.No damage to the cord was noted.Connections of the cords to the plug and socket were secure.Using a multimeter, the cords were tested for and found to have continuity.The cords were connected to an in-house temperature sensing catheter submerged in a water bath (119118 lot ngevz327) set at 37 degrees celsius, both cords connected to the catheter snuggly with a click and required force to be removed.The cords were then attached to a kilo device, both connected snuggly and required force to be removed.The temperature displayed 37.2 degrees celsius, for both cables, which is similar to the thermometer readings.The samples meet the specification "plug and jack must be firmly secured to wire.As the reported event is unconfirmed, a dhr review is not required.As the reported event is unconfirmed, a label/packaging 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 the temperature display was incorrect while using the extension cord for temperature sensing foley catheter.There was poor meshing of catheter and cable.

• 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: 16760643
• MDR Text Key: 313725295
• Report Number: 1018233-2023-02610
• 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: 07/13/2023

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 Model Number: 153622
• Device Catalogue Number: 153622
• Device Lot Number: BMGT0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/19/2023
• 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