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

Catalog Number 153622

Device Problem Incorrect Measurement (1383)

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

Event Date 04/07/2023

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 temperature varied up and down during the measurement with temperature sensing catheter on the nihon kohden monitor.Per notification received from investigator on 14jul2023, it was stated that the temperature cable was found to be out of dimensional specification during sample evaluation.

Manufacturer Narrative

The reported event was confirmed cause unknown.Two samples were confirmed to exhibit the reported failure.The device had not met specifications.Two extension cables were returned without original packaging.Photo samples were submitted, however, could not be evaluated for the reported failure.No damage to the cords were noted.Connections of the cord to the plug and socket were secure.Cable 1: 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 to 37c, the cord was then attached to a kilo device and the temperature displayed erratically from no reading and ranged from 32.7c to 36.9c, and then stabilized at 36.0c.Though the temperature displayed erratically.Using a caliper, the cable was measured, and the tip diameter was found to be out of specifications.As the out of specification measurements confirmed to not be a cause of erratic display, the reported event will be confirmed cause unknown.The second cable was then tested ad found to have continuity.The cord was connected to an in-house temperature sensing catheter submerged in a water bath set to 37c, the cord was then attached to a kilo device and the temperature displayed 37.2c, similar to the thermometer reading.A potential root cause, "wrong dimensions on competitors or our own connector".A dhr review cannot be completed as the lot number is unknown.The instructions for use were found adequate and states the following: "for use with bard temperature-sensing products and accessories".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 temperature varied up and down during the measurement with temperature sensing catheter on the nihon kohden monitor.As per notification received from investigator on 14jul2023, it was stated that the the temperature cable was found to be out of dimensional specification during sample evaluation.

• 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: 17471323
• MDR Text Key: 320728730
• Report Number: 1018233-2023-05861
• 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: 11/03/2023

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: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/17/2023
• 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