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

Model Number 153625H

Device Problems Erratic or Intermittent Display (1182); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the body temperature was not indicated correctly.

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 Description

It was reported that the body temperature was not indicated correctly.

• Brand Name: BARD® TWO PIN PLUG, MONITOR CABLE
• Type of Device: TEMPERATURE SENSING CATHETER CABLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8452689
• MDR Text Key: 140124062
• Report Number: 1018233-2019-01543
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045905
• UDI-Public: (01)00801741045905
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1