MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 UNKNOWN GUIDEWIRE

Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.
Event or Problem Description
It was reported that the customer opened the guide wire that came with the 777626 and found that there was a wax-like object attached to the guide wire.After lubricating the wire with water and rubbing it by hand, the wax did not come off and the customer was unable to continue with the trial.The solution was to open another brand of guidewire for trial.
Event or Problem Description
It was reported that the customer opened the guide wire that came with the 777626 and found that there was a wax-like object attached to the guide wire.After lubricating the wire with water and rubbing it by hand, the wax did not come off and the customer was unable to continue with the trial.The solution was to open another brand of guidewire for trial.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The reported product number is unknown.The udi number for this product is not available.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 or Problem Description
It was reported that the customer opened the guide wire that came with the 777626 and found that there was a wax-like object attached to the guide wire.After lubricating the wire with water and rubbing it by hand, the wax did not come off and the customer was unable to continue with the trial.The solution was to open another brand of guidewire for trial.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted received one photo sample that shows top view of wax-like substance on guidewire.Therefore, the reported event is confirmed.No actions can be taken at this time since a root cause was not identified.Dhr review is not required as the lot number is unknown.Labelling review is not required as labelling would not have prevented the reported event.Correction: h.The reported product number is unknown.The udi number for this product is not available.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: UNKNOWN GUIDEWIRE
• Common Device Name: UNKNOWN GUIDEWIRE
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20269355
• Report Number: 1018233-2024-05937
• Device Sequence Number: 14335493
• Product Code: EZB
• UDI-Device Identifier: 10801741014557
• UDI-Public: (01)10801741014557(17)280228(10)NGHT2327
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 12/21/2024; 01/10/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 01/10/2025; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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