MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TWO PIN PLUG, MONITOR CABLE; 2 PIN ROUND PLUG EXTENSION CORD FOR TEMP SENSE CATH

Model Number	153625H
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 while using the cord extension for temp sense catheter, the body temperature of the patient was not displayed on the monitor.Per additional information from the ibc via email 26feb2020, it was unknown if the temp sensing catheter or monitor were working correctly after the cable was changed.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (no original packaging), temperature sensing extension cord.It was noted that there were black spots and signs of possible melting on the male end of the cable.This was out of specification, which states, "no missing, damaged or incorrect components." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿user sterilizes cable.¿ the lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿do not autoclave or sterilize the monitor cable by ethylene oxide." 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.
Event or Problem Description
It was reported that while using the cord extension for temp sense catheter, the body temperature of the patient was not displayed on the monitor.Per additional information from the ibc via email 26feb2020, it was unknown if the temp sensing catheter or monitor were working correctly after the cable was changed.

• Brand Name: BARD® TWO PIN PLUG, MONITOR CABLE
• Common Device Name: 2 PIN ROUND PLUG EXTENSION CORD FOR TEMP SENSE CATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9853385
• Report Number: 1018233-2020-01930
• Device Sequence Number: 14057342
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 02/27/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1