MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD® DUAL CONNECTOR TO TWO PIN PLUG, MONITOR CABLE; TEMP SENSING EXTENSION CORD

Catalog Number	153624HM
Health Effect - Clinical Code	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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the prong was bent.
Additional Manufacturer Narrative
Received 1 used temp sensing extension cord only.The reported event was confirmed as cause unknown.During the visual inspection noted that 1 prong was bent.In order to verify the electrical continuity of cable; it was performed the following test: close de circuit of the extension cord.Set the multimeter to continuity mode.Touch the probes together.Connect the probes to the end of extension cord.Verify electrical continuity.During the electrical continuity test, it was found that the sample was acceptable.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "do not autoclave or sterilize the monitor cable by ethylene oxide.Wipe the monitor cable with a soft cloth using a solution of mild detergent and warm water or disinfectant.Dry thoroughly." (b)(4).The information provided by bard 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 bard.
Event or Problem Description
It was reported that the prong was bent.

• Brand Name: BARD® DUAL CONNECTOR TO TWO PIN PLUG, MONITOR CABLE
• Common Device Name: TEMP SENSING EXTENSION CORD
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6578723
• Report Number: 1018233-2017-02539
• Device Sequence Number: 10928171
• Product Code: EZL
• UDI-Device Identifier: 00801741045899
• UDI-Public: (01)00801741045899
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

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: 04/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1