MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE; TEMPERATURE PACING ELECTRODES

Model Number 006173P

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 confirmed with quality and manufacturing during evaluation that the temperature pacing electrodes should be inflated with air.However, the ifu has not been updated to reflect that as of yet.

Manufacturer Narrative

Per additional information from the investigation team, bd has determined that this mdr was initially reported in error as this event is not reportable.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was confirmed with quality and manufacturing during evaluation that the temperature pacing electrodes should be inflated with air.However, the ifu has not been updated to reflect that as of yet.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE
• Type of Device: TEMPERATURE PACING ELECTRODES
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8813315
• MDR Text Key: 151852625
• Report Number: 1018233-2019-04121
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• PMA/PMN Number: K800298
• 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: 08/19/2019

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: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFCX0489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR