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

Catalog Number	121620
Medical Device Problem Codes	Failure to Prime (1492); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2019).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, the device allegedly was difficult to prime.There was no patient contact.
Event or Problem Description
It was reported that prior to a biopsy, the device allegedly was difficult to prime.There was no patient contact.
Additional Manufacturer Narrative
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 was returned.A functional and dimensional evaluation was performed.The investigation is confirmed for self activation, as the cannula released when rotating the grip to retract the stylet.Upon disassembly, the cannula and stylet tangs were measured to be below specification.Therefore, the investigation is also confirmed for failure to prime.The tang measurement below specification contributed to the confirmed issues.However, it should be noted that per evaluation results, the device was returned fully primed in the "ready to fire" configuration.It possible that the return configuration contributed to tang measurement and engagement issues.It is unknown if other device handing and/or procedural factors contributed to the reported event.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.

• Brand Name: 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: 7648499
• Report Number: 2020394-2018-01013
• Device Sequence Number: 16553711
• Product Code: KNW
• UDI-Device Identifier: 00801741084621
• UDI-Public: (01)00801741084621
• 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): 08/15/2018

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: 10/31/2019
• Device Catalogue Number: 121620
• Device Lot Number: REAY1325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1