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

Model Number 153622

Device Problem Erratic or Intermittent Display (1182)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the temperature was dropped suddenly during the use and the display disappeared.It displayed without any problem after the cable was replaced.

Event Description

It was reported that the temperature was dropped suddenly during the use and the display disappeared.It was displayed without any problem after the cable was replaced.

Manufacturer Narrative

The reported event was unconfirmed.The three extension cords for the temperature sensors were received opened without their original package.Using a multimeter, the continuity was tested in both the cords.All the three cords passed the continuity test.No damage was noted to any of the three cords.No loose components of the cords were seen.As no device defects were found the device was considered not to have failed the inspection and there does not appears to be a relationship between the reported event and the device.Based on the event, it could not be determined whether the device used for treatment or diagnosis.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 of 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 was dropped suddenly during the use and the display disappeared.It was displayed without any problem after the cable was replaced.

Manufacturer Narrative

The reported event was unconfirmed.Three extension cords for temperature sensors were received opened without their original packaging.Using a multimeter, continuity was tested in both cords.All three cords passed continuity test.No damage noted to any of the three cords.No loose components of the cords were seen.As no device defects were found the device was considered not to have failed the inspection and there does not appears to be a relationship between the reported event and the device.Based on the event, it could not be determined whether the device used for treatment or diagnosis.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 of 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
• MDR Report Key: 11095629
• MDR Text Key: 224387337
• Report Number: 1018233-2020-22150
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045875
• UDI-Public: (01)00801741045875
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 01/12/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other