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 02/02/2024

Event Type  malfunction  

Event Description

It was reported that bladder temperature was measured using extension cord for temperature sensing catheter.Out of 62, 23 cases of temperature failure reported by medical safety during 19 to 26 dec.Per customer follow up received on 02feb2024, they said that there were various cases.In some cases, nothing was displayed, while in others, temperature values that were clearly wrong, such as around 34 degrees celsius, were shown.The number of each case was unknown.

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 bladder temperature was measured using extension cord for temperature sensing catheter.Out of 62, 23 cases of temperature failure reported by medical safety during 19 to 26 dec.Per customer follow up received on 02feb2024, they said that there were various cases.In some cases, nothing was displayed, while in others, temperature values that were clearly wrong, such as around 34 degrees celsius, were shown.The number of each case was unknown.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "wrong dimensions on competitors or our own connector" or "user damaged pins when inserting connector".However, there was insufficient information to confirm this potential root cause.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "bard® 3.5mm to 1/4 inch extension cable for use with bard temperature sensing products and accessories.Description 1.1 computer generated pouch label bard® 3.5mm to 1/4 inch extension cable.Component requirements: 5.1 printing: black.5.2 artwork.5.2.1 labeling cannot be changed without submitting a request to the bard medical label coordinator, who will use the appropriate bard change control system and follow the required division and corporate policies and procedures.5.3 label content: 5.3.1 the figure on page 3 indicates the pre-printed label stock as well as the variable information.5.3.2 the lot number is a variable field and will be determined at the time of manufacture.Supplier quality assurance requirements: 6.1 the supplier shall not make any changes to the materials, form, fit, function, or manufacturing.Process of components covered under this component specification without receiving prior written approval from c.R.Bard.6.2 acceptance of this specification by the supplier constitutes agreement by the supplier to produce product according to all terms of this specification." 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.

• 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: 18739738
• MDR Text Key: 335763916
• Report Number: 1018233-2024-00895
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045875
• UDI-Public: (01)00801741045875
• 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: 05/23/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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