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

Catalog Number 153624HM

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/21/2023

Event Type  malfunction  

Event Description

It was reported that the temperature sensing extension cord in the box was bent.

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.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.Visual evaluation of the returned sample noted one opened (without original packaging), used extension cord.Visual inspection of the sample noted no bend observed on the extension cord.No root cause could be found because the reported event was unconfirmed.The device history record review was not required as the reported event was unconfirmed.The labeling review was not required as the reported event was unconfirmed.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.

Event Description

It was reported that the temperature sensing extension cord in the box was bent.

• Brand Name: BARD® DUAL CONNECTOR TO TWO PIN PLUG, MONITOR CABLE
• Type of Device: TEMPERATURE SENSING EXTENSION CORD
• 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: 17491025
• MDR Text Key: 320889708
• Report Number: 1018233-2023-05964
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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 Catalogue Number: 153624HM
• Device Lot Number: NGGX3171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/07/2023
• 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