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

Model Number	153625H
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a temperature display malfunction.It was stated that the temperature was displayed on the monitor, but the temperature fluctuated wildly while using the extension cord of the temperature sensing catheter.
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 there was a temperature display malfunction.It was stated that the temperature was displayed on the monitor, but the temperature fluctuated wildly while using the extension cord of the temperature sensing catheter.
Additional Manufacturer Narrative
The reported event was unconfirmed as the device met specifications.The temperature sensing extension cable was returned without the original packaging.No signs of damage were noted on the cable.Photo samples were submitted, however, could not be evaluated for the reported failure.The resistance was measured at room temperature and found to be 0.4 ohms, which is within specifications.The cord was connected to an in-house temperature sensing catheter submerged in a water bath.(119118 lot ngevz327) water bath was held at 37 degrees celsius.While water bath temperature remained constant, the resistance values were noted to rise and stabilized at 1.352k ohms.As the reported event is unconfirmed, a dhr review and label/packaging review are 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.

• Brand Name: BARD® TWO PIN PLUG, MONITOR CABLE
• Common Device Name: TEMPERATURE SENSING EXTENSION CORD
• 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: 16007801
• Report Number: 1018233-2022-09681
• Device Sequence Number: 20211475
• 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): 03/31/2023

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
• 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: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 04/18/2023
• 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