MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD EXTENSION CABLE; EXTENSION CORD FOR TEMPERATURE SENSING CATHETER

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 11/18/2020

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 patient's body temperature was not displayed properly on the monitor after the device was connected.

Event Description

It was reported that the patients body temperature was not displayed properly on the monitor after the device was connected.

Manufacturer Narrative

The reported event was unconfirmed as the product meets the specifications.A temperature sensing catheter extension cord was returned opened without original package.No damage to the cord was noted.The connections of the cord to the plug and socket were secure.Using a multimeter the cord was tested for and found to have continuity.The cord was connected to an in house temperature sensing catheter submerged in a water bath the cord was then attached to a kilo device and was able to display the temperature.The product was used for diagnostic purposes.The product did not caused the reported failure.A potential root cause for this failure mode was unable to determine due to the reported event was unconfirmed.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore a device history record review was not required.Per investigation a labeling review was not required.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 CORD FOR TEMPERATURE SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11007636
• MDR Text Key: 221497024
• Report Number: 1018233-2020-21676
• 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): Y
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other