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

Model Number	153625H
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
Date of Event	03/01/2019
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 body temperature was not indicated correctly.
Additional Manufacturer Narrative
The reported event was confirmed.A root cause could not be determined.The inspector received one temperature sensing cable with no packaging.It was noted that the connections (male connection) were bent.No missing, damaged or incorrect components are considered acceptable.The lot number is unknown; therefore, the device history record could not be reviewed.According to sec.801.116, medical devices having commonly known directions shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses and are known to the ordinary individual.Product catalog number 153625h was deemed by appropriate subject matter experts (sme) to be within this definition.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.
Event or Problem Description
It was reported that the body temperature was not indicated correctly.

• Brand Name: BARD® TWO PIN PLUG, MONITOR CABLE
• Common Device Name: TEMPERATURE SENSING CATHETER CABLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8452689
• Report Number: 1018233-2019-01543
• Device Sequence Number: 354786
• 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: distributor,other
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 03/21/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1