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

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported that the prong was bent.

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 Description

It was reported that the prong was bent.

• Brand Name: BARD® DUAL CONNECTOR TO TWO PIN PLUG, MONITOR CABLE
• Type of Device: TEMP SENSING EXTENSION CORD
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6578723
• MDR Text Key: 75727046
• Report Number: 1018233-2017-02539
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045899
• UDI-Public: (01)00801741045899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 153624HM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1