MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAGNUM CORE BIOPSY NEEDLES; MAGNUM NEEDLE 18G

Model Number MN1820

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (08/2020).

Event Description

It was reported that during a biopsy procedure, a metal fragment was found in the tissue collected.There was no reported patient injury.

Manufacturer Narrative

H10: 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 magnum needle and metal fragment were returned.A visual and microscopic evolution was performed.The metal fragment appears to be a wire segment measuring approximately 2.54cm in length.The wire segment appears to exhibit district cuts at each end.The wire segment is noted to be deformed/bent into a g-shape configuration.Inspection of the needle noted nothing remarkable.No anomalies or damage was noted to the sample notch.Based on the available evidence, foreign material present in the device cannot be determined as the sample was returned open and the as received sealed configuration of the device cannot be evaluated.Therefore, the investigation will remain inconclusive.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.It should be noted that per manufacturing procedure, (mp6000028 rev.19), all magnum needles must be 100% inspected for visible damages such as kinks, bent needles prior packaging.Also, the operator verifies the cannula and stylet by taking a magnum set and a tray, activating an ionized air gun, blowing the needle and the tray, then place the magnum set inside the tray.Therefore, it is unlikely that the reported 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.H11: d1, d10, h3, h6 (method 1, results 1).H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that during an ultrasound guided prostate biopsy through normal density tissue, a metal fragment was found in the tissue collected.A coaxial was not used.It was further reported that the procedure was completed using another device.There was no reported patient injury.

• Brand Name: MAGNUM CORE BIOPSY NEEDLES
• Type of Device: MAGNUM NEEDLE 18G
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8113139
• MDR Text Key: 128724793
• Report Number: 2020394-2018-02128
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084355
• UDI-Public: (01)00801741084355
• Combination Product (y/n): N
• PMA/PMN Number: K934370
• 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: 04/29/2019

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
• Device Operator: Health Professional
• Device Model Number: MN1820
• Device Catalogue Number: MN1820
• Device Lot Number: REBY2586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 04/27/2019
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1