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

Model Number 153622

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 12/17/2021

Event Type  malfunction  

Event Description

It was reported that a slight touch caused an erratic display or a low temperature display (batch# bmfu0001).There were many of the similar problems since the 153622-model number was introduced (batch# unk).The customer complained that the strength of the cable had been reduced.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for diagnostic purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "wrong dimensions on competitors or our own connector".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".The device was not returned.

Event Description

It was reported that a slight touch caused an erratic display or a low temperature display (batch# bmfu0001).There were many of the similar problems since the 153622-model number was introduced (batch# unk).The customer complained that the strength of the cable had been reduced.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13120367
• MDR Text Key: 286666368
• Report Number: 1018233-2021-08577
• 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: 04/08/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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