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

Model Number 153622

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 316873326
• Report Number: 1018233-2023-04139
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045875
• UDI-Public: (01)00801741045875
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/10/2023
• 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
• Patient Outcome(s): Other