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

Model Number 153622

Device Problem Incorrect Measurement (1383)

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

Event Date 03/01/2023

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 display disappeared, or temperature was displayed lower than actual after 35 days of use.Per notification received from investigator on (b)(6)2023 , it was reported that the during evaluation, the dimensions of the cable plug were found to be out of specifications.

Event Description

It was reported that the temperature display disappeared, or temperature was displayed lower than actual after 35 days of use.Per notification received from investigator on 01 mar 2023, it was reported that the during evaluation, the dimensions of the cable plug were found to be out of specifications.

Manufacturer Narrative

The reported event is confirmed, supplier manufacturing related.Six extension cords were returned without the original packaging.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 at 37 degrees c, 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.".Using a caliper the cable was measured and the tip and indentation diameter were found to be out of specifications; as the out of specification measurements confirmed to not be a cause of erratic display.As the cable is supplied by wonik corporation u.S.A., ltd.(f.K.A international importers) this event will be confirmed supplier related.Cords 2, 3, 4, 5, and 6 were connected to an in-house temperature sensing catheter submerged in a water bath at 37 degrees, the cord was then attached to a kilo device and the temperature displayed 37.3c, 37.2, 37.2c, 371.1c and 37.2c respectively, similar to the thermometer reading.A potential root cause for this event could be operator error.The device was used for diagnostic purposes.The lot number is unknown; therefore, the device history record could not be reviewed.A label/pack review is not required as a review of the label could not have prevented the reported event.Corrections: a, f, h.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 evaluated.

• 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: 16590181
• MDR Text Key: 311791369
• Report Number: 1018233-2023-01936
• 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: 06/20/2023

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: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/07/2023
• 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