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

Model Number	MN2020
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 as well as photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 07/2022).
Event or Problem Description
It was reported that during an ultrasound guided prostate biopsy, the device was allegedly difficult to remove.It was further reported that the device needle was allegedly found bent.A coaxial was not used.The procedure was completed using another device.There was no reported patient injury.
Additional 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.Investigation summary: one bard magnum biopsy needle for evaluation.During visual evaluation, the device appeared clean and the spacer attached to the needle at the hubs.Distal tip of stylet appeared bend.It was also noted that the sample notch was bent forwards when positioned on a flat surface.The functional testing was not performed, due to the condition of sample.Upon, dimensional observation, the notch bend was measured and found to be not within specification.Then the notch thickness was measured and found to be within specification.Therefore, the investigation is confirmed for the reported needle bent as the distal tip of stylet appeared bend.However, the investigation is inconclusive for the reported difficult to remove as the functional testing was not performed.Three electronic photos were provided and reviewed.All the three photos shows only the half part of the magnum needle and it was noted that the distal tip of stylet appeared bent.Based on the photo review, the reported bent needle can be confirmed.Therefore the investigation is confirmed for the reported bent needle and inconclusive for the reported difficult to remove.A definitive root cause for the alleged bent needle and difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 07/2022), g3, h6 (method).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 or Problem Description
It was reported that during an ultrasound guided prostate biopsy, the device was allegedly difficult to remove.It was further reported that the device needle was allegedly found bent.A coaxial was not used.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: MAGNUM NEEDLE
• Common Device Name: 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. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13785632
• Report Number: 2020394-2022-00174
• Device Sequence Number: 1714411
• Product Code: FCG
• UDI-Device Identifier: 00801741084416
• UDI-Public: (01)00801741084416
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K934370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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 Model Number: MN2020
• Device Catalogue Number: MN2020
• Device Lot Number: REDV1573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male