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

Catalog Number	MN1616
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2016
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 is currently underway.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 an ultra-sound guided renal biopsy, the biopsy needle was allegedly identified to be a different size than what the label indicated.The procedure was completed with another device.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual inspection: as received, the cannula hub was retracted towards the stylet hub, thus exposing the sample notch.The mn1616 needle should have 14 reference markings on the cannula.The reference markings on the returned needle cannula were counted and there were only 8 reference markings, which is consistent with a mn1610 needle.Functional/performance evaluation: the device was returned and a dimensional evaluation was performed.A functional/performance evaluation was not applicable for this type of event.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 returned device was measured and found to be within specification for a mn1610 needle.However, the investigation was inconclusive for a mislabeling, as the packaging was returned opened.Per the evaluation results, the returned sample was found to be within specification for a mn1610 needle instead of the labeled mn1616.After review of the manufacturing records, it was unlikely that a mix-up occurred at the manufacturing site, as there were no mn1610 needles manufactured several days before and after the affected lot.Additionally, a sales review showed that both mn1616 and mn1610 needles were sold to the user facility.Therefore, it was possible that a mix-up could have occurred at the facility.However, based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: how supplied: the magnum instrument is sold nonsterile and is to be decontaminated and processed (e.G.Cleaned, lubricated, etc.) prior to use by the end-user.Magnum biopsy needles are sold sterile for single patient use only and are available in various gauge sizes and lengths.The magnum needles are supplied sterile and nonpyrogenic unless the package has been opened or damaged.Precautions: inspect the instrument for signs of deterioration or damage (cracking, blistering, separation of coating, pitting).Do not use if deterioration or damage is observed.
Event or Problem Description
It was reported that during preparation for an ultra-sound guided renal biopsy, the biopsy needle was allegedly identified to be a different size than what the label indicated.The procedure was completed with another device.There was no reported patient contact.

• Brand Name: MAGNUM BIOPSY DISPOSABLE NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6042608
• Report Number: 2020394-2016-00988
• Device Sequence Number: 10860441
• Product Code: FCG
• UDI-Device Identifier: 00801741084300
• UDI-Public: (01)00801741084300(17)190228(10)REAP1550
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K934370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2016

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: 02/28/2019
• Device Catalogue Number: MN1616
• Device Lot Number: REAP1550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1