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

Catalog Number	153624HM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
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 the black temperature cord was frequently broken.
Event or Problem Description
It was reported that the black temperature cord was frequently broken.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.Visual evaluation of the returned photo sample noted one opened (without original packaging), used temp sensing extension cord.Visual inspection of the photo sample noted that one end of the cable cord connector was broken/cut off.A potential root cause for this failure mode could be ¿"user unfamiliar with device or procedure; user technique".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: "for use with compatible 400-series temperature monitors" "do not autoclave or sterilize the monitor cable by ethylene oxide." 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® DUAL CONNECTOR TO TWO PIN PLUG, MONITOR CABLE
• Common Device Name: DUAL CONNECTOR TO TWO PIN PLUG, 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: 18110428
• Report Number: 1018233-2023-08039
• Device Sequence Number: 7891495
• Product Code: EZL
• UDI-Device Identifier: 00801741045899
• UDI-Public: (01)00801741045899
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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 Catalogue Number: 153624HM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 02/16/2024
• 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