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

Catalog Number	121820
Medical Device Problem Codes	Bent (1059); Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event 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 the biopsy procedure the stylet was allegedly bent and cracked near the sample notch of the device.There was no patient contact.
Additional Manufacturer Narrative
The evaluation was unconfirmed for the alleged break, only the reported bend was confirmed.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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one monopty biopsy needle and five electronic photos were provided for review.A photo review and visual/dimensional evaluation was performed.Based on the photo review and sample evaluation, the investigation is confirmed for bent needle as a backward bend was noted at the sample notch.However, no other anomalies were noted with the needle.Therefore, the investigation is unconfirmed for the alleged crack/break near the sample notch.The definitive root cause could not be determined based upon available information.It is unknown if device handling issues and/or device storage at the facility contributed to the reported event.It should be noted that per manufacturing procedure, mp6000007, rev.20, all monopty devices are 100% inspected for damage and functionally tested during manufacturing.Therefore, it is unlikely that the issue is manufacturing related.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 during preparation for a kidney biopsy procedure the stylet was allegedly bent and cracked near the sample notch of the device.It was further reported that the needle guard/tip protector was in place upon opening the package.There was no patient contact.

• Brand Name: MONOPTY BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7470789
• Report Number: 2020394-2018-00512
• Device Sequence Number: 19150883
• Product Code: KNW
• UDI-Device Identifier: 00801741084652
• UDI-Public: (01)00801741084652
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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: 01/31/2021
• Device Catalogue Number: 121820
• Device Lot Number: RECN1137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1