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

Catalog Number	520007P
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.H3 other text : device was not returned.
Event or Problem 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.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (with original label), used temporary pacing electrode catheter.Visual inspection of the sample noted using the luer lock catheter balloon was inflated with 1.5 cc air, stopcock closed syringe removed.Allowed to rest with no leaks noted for one minute.The balloon inflated with no issues, stopcock opened, and balloon deflated.No root cause could be found because the reported event was unconfirmed.Dhr is not required since the reported failure was unconfirmed.As the reported event is unconfirmed a labeling review is not required.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
• Common Device Name: 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: 18893637
• Report Number: 1018233-2024-01300
• Device Sequence Number: 6410262
• Product Code: LDF
• UDI-Device Identifier: 00801741011535
• UDI-Public: (01)00801741011535
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K800298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 520007P
• Device Lot Number: GFHU0871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown