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

Model Number	153622
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
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 temperature was not displayed when connected, 50 percent of the time it was connected.Per notification received from investigator on (b)(6) 2023, it was stated that during evaluation the sample was found to not meet dimensional requirements.
Event or Problem Description
It was reported that temperature was not displayed when connected, 50 percent of the time it was connected.Per notification received from investigator on 17may2023, it was stated that during evaluation the sample was found to not meet dimensional requirements.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.A potential root cause for this failure was "wrong dimensions on competitors or our own connector" or "user damaged pins when inserting connector".The lot number was 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 actual/suspected device was inspected.

• 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: 17097441
• Report Number: 1018233-2023-04139
• Device Sequence Number: 7826304
• 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): 10/05/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 10/10/2023
• 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