MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

Catalog Number	211610
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/06/2018
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 provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date: (b)(6) 2021).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 prior to a biopsy, allegedly a round transparent plastic piece was found.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required, however requested.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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one sealed monopty device and two electronic photos were provided for evaluation.Based on the photo review, a transparent plastic within the packaging can be confirmed.The monopty device was returned sealed within the tyveck packaging and a small, round transparent plastic was noted to be free floating within.No visual anomalies were noted to the device.The transparent plastic was removed from the packaging and aligned with the hanging tab hole of the packaging tray, thus confirming the transparent plastic to be part of the packaging and not foreign material to the device.Therefore, the investigation is unconfirmed for the reported misassembled device and foreign material issues.Furthermore, the investigation is confirmed for a packaging issue, as the transparent plastic tab was found within the sealed packaging.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that prior to a biopsy, allegedly a round transparent plastic piece was found.There was no patient contact.

• Brand Name: BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7831174
• Report Number: 2020394-2018-01606
• Device Sequence Number: 2336563
• Product Code: KNW
• UDI-Device Identifier: 00801741084713
• UDI-Public: (01)00801741084713
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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: 211610
• Device Lot Number: RECN2777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 01/12/2019
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1