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); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
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.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 or Problem Description
It was reported that after several uses, it no longer displayed the normal temperature.The crack in the connector on the side that connected to the temperature sensor catheter was intentionally cut by the hospital technician to check the structure of the product.Per follow-up information received from ibc on (b)(6) 2023, stated that the fitting issues were not reported.  it was reported that after several uses, it no longer displayed the normal temperature.The crack in the connector on the side that connects to the temperature sensor catheter was intentionally cut by the hospital technician to check the structure of the product.The user cut the connector after the event occurred.
Event or Problem Description
It was reported that after several uses, it no longer displayed the normal temperature.The crack in the connector on the side that connected to the temperature sensor catheter was intentionally cut by the hospital technician to check the structure of the product.Per follow-up information received from ibc on (b)(6) 2023, stated that the fitting issues were not reported.It was reported that after several uses, it no longer displayed the normal temperature.The crack in the connector on the side that connects to the temperature sensor catheter was intentionally cut by the hospital technician to check the structure of the product.The user cut the connector after the event occurred.
Additional Manufacturer Narrative
Upon further review, bd has determined that this event is not reportable.H11:section a through f - the information provided by bd represents all of 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.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17037782
• Report Number: 1018233-2023-03969
• Device Sequence Number: 17883930
• 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): 07/19/2023

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: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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