MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® EXTENSION CABLE

Model Number	153622
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
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.H3: the device was not returned.
Event or Problem Description
It was reported that temperature was not properly displayed on monitor.When connecting the 153622 cable to measure the temperature, the monitor did not display the temperature.When the customer tried again later, it was displayed, but when they slightly touched the connection between the catheter and the 153622 cable during the display, the temperature display disappeared and then reappeared.As per the additional information received via ibc on 12apr2023, it was reported that when the user slightly touched the connection between the catheter and the 153622 cable during the display, the temperature display disappeared and then reappeared.According to this statement, the fitting issue between the catheter and the 153622 cable might have caused the erratic display.However, since the sample is not available, we cannot confirm whether it was a fitting issue.
Event or Problem Description
It was reported that temperature was not properly displayed on monitor.When connecting the 153622 cable to measure the temperature, the monitor did not display the temperature.When the customer tried again later, it was displayed, but when they slightly touched the connection between the catheter and the 153622 cable during the display, the temperature display disappeared and then reappeared.As per the additional information received via ibc on 12apr2023, it was reported that when the user slightly touched the connection between the catheter and the 153622 cable during the display, the temperature display disappeared and then reappeared.According to this statement, the fitting issue between the catheter and the 153622 cable might have caused the erratic display.However, since the sample is not available, we cannot confirm whether it was a fitting issue.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned for evaluation and further investigation was not conclusive.Though a specific cause cannot be determined, potential root causes for this failure are "wrong dimensions on competitors or our own connector" or "user damaged pins when inserting connector".The device was not returned for evaluation.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 bard temperature-sensing products and accessories".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 device was not returned.

• Brand Name: BARD® EXTENSION CABLE
• Common Device Name: EXTENSION 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: 16837342
• Report Number: 1018233-2023-03013
• Device Sequence Number: 20548308
• Product Code: EZL
• UDI-Device Identifier: 00801741045875
• UDI-Public: (01)00801741045875
• 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: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: 153622
• Device Catalogue Number: 153622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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