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

Catalog Number	150NSS35
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when opened the guidewire packaging, after lubricating with sterile water, one guidewire was found to have a layer peeling off the body.After opening a new package of guidewire, the guidewire body had burrs; opening another new package of guidewire, the guidewire body had burrs and layer peeling.After opening another new package of guidewire, the guidewire had no abnormalities, and the surgery proceeded smoothly without any impact.
Additional Manufacturer Narrative
The complete initial reporter's facility name is (b)(6) university.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.H11: sections 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: NICORE NITINOL GUIDEWIRE
• Common Device Name: 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, GA 30014 ; 7707846100
• MDR Report Key: 23769535
• Report Number: 1018233-2025-10933
• Device Sequence Number: 21254552
• Product Code: EZB
• UDI-Device Identifier: 00801741051524
• UDI-Public: (01)00801741051524(11)250311(17)290131(10)NGKP1074
• 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
• Report Date (Section B): 06/04/2026

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 Catalogue Number: 150NSS35
• Device Lot Number: NGKP1074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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