MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DUALOK LOCALIZATION WIRE; BIOPSY INSTRUMENT

Model Number	LW0107
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2024).
Event or Problem Description
It was reported that during a mri guided breast biopsy procedure, the device allegedly mislabeled.There was no reported patient injury.
Event or Problem Description
It was reported that during a mri guided breast biopsy procedure, the device was allegedly mislabeled.It was further reported that the device was used in incorrect procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.One electronic photo was reviewed.The photo shows the label part part of the device and it is verified with the system.In that label some marker stains are there stating test mri.Hence the investigation is unconfirmed for the reported labelling issue as the label provides the correct information and the investigation is confirmed for improper or incorrect procedure or method as the user used the device with mri.A definitive root cause for the alleged labelling issue could not be determined based upon the provided information.However, the definitive root cause for the alleged improper or incorrect procedure or method is determined to be user related.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 05/2024), g3, h6(method).H11: section a through f ¿ the information provide 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: DUALOK LOCALIZATION WIRE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• 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: 13041083
• Report Number: 2020394-2021-02085
• Device Sequence Number: 5364507
• Product Code: GDF
• UDI-Device Identifier: 00801741079757
• UDI-Public: (01)00801741079757
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: UNKNOWN
• 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): 05/16/2022

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 Model Number: LW0107
• Device Catalogue Number: LW0107
• Device Lot Number: REFU0272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 12/19/2021
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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