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

Catalog Number 121820

Device Problems Bent (1059); Break (1069); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7470789
• MDR Text Key: 106846280
• Report Number: 2020394-2018-00512
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084652
• UDI-Public: (01)00801741084652
• Combination Product (y/n): N
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1