MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GUIDEWIRE; PORT AND CATHETER ACCESSORIES

Catalog Number	5583705
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during evaluation of the lot sample, component misassembled was allegedly identified.There was no reported patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one vascath guidewire sealed lot sample was received for evaluation.Gross visual evaluation was performed.The stiff tip was found in the distal end of dispenser; therefore, the investigation is confirmed for component misassembled as the flexible tip should be in the distal end of the dispenser.The root cause is manufacturing related.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2025) 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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one vascath guidewire sealed lot sample was received for evaluation.Gross visual evaluation was performed.The stiff tip was found in the distal end of dispenser; therefore, the investigation is confirmed for component misassembled as the flexible tip should be in the distal end of the dispenser.The root cause is manufacturing related.A quality event was opened to address guidewires incorrectly loaded into dispensers.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3.H11: d4 (unique identifier (udi) #).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 during evaluation of the lot sample, component misassembled was allegedly identified.There was no reported patient contact.

• Brand Name: GUIDEWIRE
• Common Device Name: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19353920
• Report Number: 3006260740-2024-02459
• Device Sequence Number: 12688658
• Product Code: DQX
• UDI-Device Identifier: 00801741085451
• UDI-Public: (01)00801741085451(11)200513(17)250331(10)REER0990
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K770977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 03/31/2025
• Device Catalogue Number: 5583705
• Device Lot Number: REER0990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2020
• 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
• Patient Sex: Unknown