MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAGNUM BIOPSY DISPOSABLE NEEDLE; BIOPSY INSTRUMENT

Catalog Number MN1410

Device Problems Difficult to Remove (1528); Failure to Obtain Sample (2533); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted as the lot number is unknown.Visual/microscopic inspection: the device was not returned; therefore, a visual/microscopic inspection could not be performed.Functional/performance evaluation: the device was not returned; therefore, a functional/performance evaluation could not be performed medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is inconclusive, as the samples were not returned for evaluation.Per the reported event details, the device was dry fired prior to use on patient.Per the instructions for use (ifu) " never test the instrument while the needle is installed in the instrument.This could result in needle damage and/or patient/user injury".While a definitive root cause could not be determined based upon available information, dry firing the device could have contributed to the reported event.Labeling review: the current (magnum biopsy disposable needle) ifu provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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 an ultrasound guided breast biopsy, the healthcare provider reported that tissue samples could not be obtained with the biopsy needle.The healthcare provider alleged difficulty removing the biopsy needle from the target tissue.Reportedly, the procedure was completed with another device.There was no reported patient injury.

• Brand Name: MAGNUM BIOPSY DISPOSABLE NEEDLE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5747046
• MDR Text Key: 48100288
• Report Number: 2020394-2016-00568
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K934370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MN1410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1