MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MAGNUM CORE BIOPSY NEEDLE; BIOPSY INSTRUMENT

Catalog Number	MN1610
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number of the device was not provided.The return of the device is pending.The investigation is currently underway.The information provided by bard represents all of 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 bard.
Event or Problem Description
It was reported that during preparation for a biopsy, an alleged foreign material was found between the cannula and stylet.It was further reported that the procedure was performed with another device.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one magnum biopsy needle and three electronic photos were provided for evaluation.The investigation was inconclusive for foreign material present on device, as the device was returned in an open configuration and the initial out of package configuration could not be reproduced.However, no anomalies were noted with the returned open sample or photos provided.Based on the photo review, foreign material cannot be confirmed.Based upon available information, the definitive root cause could not be determined.It was unknown if procedural issues contributed to the reported event.It should be noted that per manufacturing procedures, all magnum needles are 100% visually inspected before and after sealing.Therefore, it was unlikely that the root cause is manufacturing related.Labeling review: the current ifu (instructions for use) states: how supplied: the magnum needles are supplied sterile and nonpyrogenic unless the package has been opened or damaged.Bard magnum biopsy needle preparation: using aseptic technique, remove the needle from the package and from the protective sheath.Precaution: before using, inspect the needle components for damage.Do not use if the needle components are damaged.The information provided by bard represents all of 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 bard.
Event or Problem Description
It was reported that during preparation for a biopsy, an alleged foreign material was found between the cannula and stylet.It was further reported that the procedure was performed with another device.There was no patient contact.

• Brand Name: BARD MAGNUM CORE BIOPSY NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7175887
• Report Number: 2020394-2017-01899
• Device Sequence Number: 13476884
• Product Code: FCG
• UDI-Device Identifier: 00801741084287
• UDI-Public: (01)00801741084287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K934370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 12/31/2019
• Device Catalogue Number: MN1610
• Device Lot Number: REBN0541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1