MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TWO PIN PLUG, MONITOR CABLE

Model Number	153625H
Medical Device Problem Codes	No Display/Image (1183); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
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.
Event or Problem Description
It was reported that the temperature sensor was defective on the day of use.Per additional information via email from ibc on 19jan2022, temperature sensor is only mentioned as defective, and the details are unknown.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.A temperature sensing extension cord was returned opened without original packaging.A photo sample was also returned.No damage was noted in the photo sample, and no testing was able to be completed.The physical sample was evaluated.No damage to the cord was noted.Sample meets visual requirements.Using a multimeter, the resistance was measured at room temperature.Resistance was taken and found to be 0.04 ohms, which does not meet specification.The cord was connected to an in-house temperature sensing catheter submerged in a water bath.Water bath was held at 37 degrees celsius.While water bath temperature remained constant, the resistance values changed erratically.The product was used for diagnostic purposes.A potential root cause for this failure mode could be, "user damaged pins when inserting connector".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "for use with compatible 400-series temperature monitors do not autoclave or sterilize the monitor cable by ethylene oxide.Wipe the monitor cable with a soft cloth using a solution of mild detergent and warm water or disinfectant.Dry thoroughly." the actual/suspected device was inspected.
Event or Problem Description
It was reported that the temperature sensor was defective on the day of use.Per additional information via email from ibc on 18jan2022, stated that the temperature sensor was only mentioned as defective, and the details were unknown.

• Brand Name: BARD® TWO PIN PLUG, MONITOR CABLE
• Common Device Name: MONITOR 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13390004
• Report Number: 1018233-2022-00222
• Device Sequence Number: 4678312
• Product Code: EZL
• UDI-Device Identifier: 00801741045905
• UDI-Public: (01)00801741045905
• 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): 08/16/2022

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 Model Number: 153625H
• Device Catalogue Number: 153625H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 01/29/2022
• Supplement Report FDA Received Date: 08/17/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown