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

Catalog Number	LW0107
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 12/2025).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.H3 other text : device pending return.
Event or Problem Description
It was reported that prior to a biopsy procedure, the device allegedly had labelling problem, as the label has the right indication but the rest of the packaging had different product description.There was no patient contact.
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 provided and it was reviewed.In that provided photo, three product labels were shown; in that product labeling the mentioned lot and catalogue details were matches with tw details & also it is belongs to dualok localization wire but the product packaging information states the magnum biopsy needle information.Based on the photo review, the reported failure can be confirmed.Therefore, the investigation is confirmed for the reported device markings / labelling problem issue as the product packaging information states the magnum needle and the label information states the dualok localization wire in the provided photo for review.A definitive root cause for the alleged device markings / labelling problem issue is determined to be manufacturing 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) found that the product labeling was inadequate.By comparing the received label sticker against document "(b)(4)" (rev.3), it was noted that everything mentioned in the product label sticker was verified and it matched with the document.By comparing the received pouch against document "(b)(4)" (rev.2), it was noted that the product name, copyright information and pk number which was mentioned in the pouch was incorrect.The information which was mentioned in the received pouch was belongs to the magnum biopsy device (as the product was dualok localization wire).H10: d4 (expiration date: 12/2025).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.
Event or Problem Description
It was reported that prior to a biopsy procedure, the device allegedly had labelling problem, as the label has the right indication but the rest of the packaging had different product description.There was no patient contact.

• 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: 18709290
• Report Number: 2020394-2024-00206
• Device Sequence Number: 8331866
• 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): 03/05/2024

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 Catalogue Number: LW0107
• Device Lot Number: REHN3500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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
• Patient Sex: Unknown