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

Model Number 153622

Device Problems Erratic or Intermittent Display (1182); Device Handling Problem (3265)

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

Event Date 11/30/2020

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 inaccurately displayed from temperature sensing foley catheter.Per follow up via regional partner on 11dec2020, based on the attachment, it was mentioned as the user felt that the area around the connection was weak and would heal if they play with it a little.

Manufacturer Narrative

Per investigator evaluation, bd has determined that this mdr event is not reportable.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 was inaccurately displayed.Per follow up information received via regional partner on 11dec2020, based on the attachment, it was mentioned as the user felt that the area around the connection was weak and would heal if they play with it a little.Per email from ibc on 01sep2021, this event occurred when the temperature sensing catheter cable was connected to fukuda¿s monitor and ucc quality engineering confirmed that the cable can only be used with bard products (i.E.Criticore monitor) and was not intended for the fukuda monitor.

• 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: 11057544
• MDR Text Key: 226104841
• Report Number: 1018233-2020-21918
• 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
• Report Date: 09/17/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other