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

Catalog Number 153622

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 09/14/2023

Event Type  malfunction  

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.

Event Description

It was reported that the temperature display became unstable due to a possible connection problem with the monitor.The representative could not confirm the number but confirmed 13 black cables, where 12 are case bull type 153622.One bottle was confirmed to be j-sol.13 checked for the appearance of the cables but could not confirm.Per follow up information received via ibc on (b)(6) 2023, the customer clarified that total 12 cables were affected and there was an another product mixed with the 12 cables already reported.They clarified that there was no fitting issue.

Event Description

It was reported that the temperature display became unstable due to a possible connection problem with the monitor.The representative could not confirm the number but confirmed 13 black cables, where 12 are case bull type 153622.One bottle was confirmed to be j-sol.13 checked for the appearance of the cables but could not confirm.Per follow up information received via ibc on 22sep2023, the customer clarified that total 12 cables were affected and there was an another product mixed with the 12 cables already reported.They clarified that there was no fitting issue.

Manufacturer Narrative

The reported event is confirmed, cause unknown.Twelve extension cord was returned without the original packaging.A potential root cause for this failure is "wrong dimensions on competitors or our own connector" or "user damaged pins when inserting connector".Photo samples were submitted, however, could not be evaluated for the reported failure.No damage to the cord was noted during evaluation of the physical sample.Connections of the cord to the plug and socket were secure.Using a multimeter, the cords were tested for and found to have continuity.Cord 1 was connected to an in-house temperature sensing catheter submerged in a water bath (119118 lot ngevz327) at 37 degrees, the cord was then attached to a kilo device and the temperature displayed erratically from no reading and ranged from 36.1 c to 37.0c.Though the temperature displayed erratically, the sample meets the specification "plug and jack must be firmly secured to wire.".The device history record review could not be performed without a lot number.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 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
• 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: 17887142
• MDR Text Key: 325121167
• Report Number: 1018233-2023-07230
• Device Sequence Number: 1
• Product Code: EZL
• 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: 01/31/2024

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: 153622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/05/2024
• 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