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

Model Number	1410MSK
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	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a breast biopsy procedure, the inner needle allegedly bent while penetrating and the cutting didn't go all the way.It was further reported that the needle was allegedly removed by excessive force.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 06/2025).
Event or Problem Description
It was reported that during a breast biopsy procedure, the inner needle allegedly bent while penetrating and the cutting didn't go all the way.It was further reported that the needle was allegedly removed by excessive force.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one mission biopsy device was received for evaluation.During visual evaluation, the device appeared to have residue throughout and the device was returned in initial configuration with the cannula at the 00 mm position and the sample notch was not exposed.It was noted that the sample notch was bent backwards and no other visual anomalies were noted to the device.During dimensional observations, the acceptable range for the notch thickness is 0.0215" ± 0.0040".The notch thickness was measured, and found to be 0.0218¿.This measurement was within the acceptable range.The functional testing was not performed, due to the nature of the complaint.Therefore, the investigation is inconclusive for the reported difficult to remove as the condition of the use could not be replicated, however, the investigation is confirmed for the reported bent needle as the sample notch was noted to be bent.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 (expiry date: 06/2025), g3.H11: h6 (method, result, conclusion).H11: section a through f: the information provide by bd represents all 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.H3 other text : see h10.

• Brand Name: MISSION
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16616734
• Report Number: 2020394-2023-00198
• Device Sequence Number: 17710328
• Product Code: KNW
• UDI-Device Identifier: 00801741142543
• UDI-Public: (01)00801741142543
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K171953
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 1410MSK
• Device Catalogue Number: 1410MSK
• Device Lot Number: 0001475757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 03/25/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown