MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX TEMPERATURE PACING ELECTRODE CATHETER

Catalog Number 520007P

Device Problem Failure to Infuse (2340)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that 3 out of 5 temporary pacing electrode catheters were defective.Once inserted, the balloons will not inflate.Lot number was gfhu0871.Customer had balloons for samples if needed.They only had one of the balloons kept after use.They were not positive of the lot number of the other 2, but would like to assume they were the same lot, since they had them all out.But they cannot confirm.They had the one from tuesday lot # gfhu0871 and they have one more of that lot unopened.They ordered and received a new box with a different lot # and put those out.

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.

• Brand Name: LATEX TEMPERATURE PACING ELECTRODE CATHETER
• Type of Device: TEMPERATURE PACING 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: 18893512
• MDR Text Key: 337761897
• Report Number: 1018233-2024-01298
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011535
• UDI-Public: (01)00801741011535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520007P
• Device Lot Number: GFHU0871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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