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

Catalog Number	121810
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
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 provided.The device history records are currently under review.The device is not available for return.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 a breast biopsy, the physician alleged that the needle was that of a 16g and not the labeled 18g.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: visual inspection not performed as the sample was not returned.Functional/performance evaluation: functional testing not performed as the sample was not returned.Medical records review: review not performed as medical records were not provided.Image/photo review: one electronic photo was received and reviewed.The photo shows a scanned copy of the package labeling.The label clearly shows lot# rezi1868 and cat# 121810.No anomalies were noted with the label and product description.Conclusion: one electronic photo was provided for review.Based on the photo review, a device marking issue could not be confirmed and no objective evidence was provided.A review of manufacturing records and sales from the facility was performed based on the lot number provided and no anomalies could be found to confirm the reported event.Therefore, the investigation is inconclusive for the reported event.Per the sales review, it was noted that the facility had received a purchase order for both monopty catalogs 121810 and 121610 in october 2016, while the event occurred in (b)(6) 2017.While a definitive root cause could not be determined based upon the available information.It is unknown if device handling for the two available monotpy catalogs at the facility contributed to the reported event.It should be noted that per the evaluation results, the initial and final article inspection for the lot in question confirmed no abnormalities regarding needle gauge.Additionally, a review of prior and post manufactured lots to the lot in question noted no correlation for potential mix-up issues.Therefore, it was unlikely that the event is related to manufacturing issue.Labeling review: the current ifu (instructions for use) states: general information and device description: the bard monopty disposable core biopsy instrument is a single use core biopsy device.It is available in several needle gauge sizes and lengths.Precautions: before using, inspect the needle for damaged point, bent shaft or other imperfections that would prevent proper function.If the needle components are damaged or bent, do not use.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 a breast biopsy, the physician alleged that the needle was that of a 16g and not the labeled 18g.There was no reported patient injury.

• 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: 6616806
• Report Number: 2020394-2017-00580
• Device Sequence Number: 10994529
• Product Code: KNW
• UDI-Device Identifier: 00801741084638
• UDI-Public: (01)00801741084638(17)180928(10)REZI1868
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2017

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: 09/28/2018
• Device Catalogue Number: 121810
• Device Lot Number: REZI1868
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1