MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER

Model Number 006173P

Device Problem Inadequate Instructions for Healthcare Professional (1319)

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

Event Date 12/08/2022

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 distal (-) message was printed on both electrodes.When the user opened the package, they realized that both cables of the temporary pacing electrode had "distal (-)" printed on them, so they did not know which one was the real distal and negative and which was the positive.The rest of the temporary pacing electrode seemed ok.They did not use the device.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.A potential root cause for this event could be operator error.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required as a review of the label could not have prevented the reported event.H11: section a through f - the information provided by bard 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 bard.H3 other text: the actual/suspected device was inspected.

Event Description

It was reported that the distal (-) message was printed on both electrodes.When the user opened the package, they realized that both cables of the temporary pacing electrode had "distal (-)" printed on them, so they did not know which one was the real distal and negative and which was the positive.The rest of the temporary pacing electrode seemed ok.They did not use the device.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
• Type of Device: BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER
• 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: 16068600
• MDR Text Key: 308258689
• Report Number: 1018233-2022-09987
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFGS2561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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