MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR MRI DRIVER; REUSABLE BIOPSY

Model Number	DRENCORMR
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the serial 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.(expiration date: 09/2045).
Event or Problem Description
It was reported that during a breast biopsy procedure, the device allegedly failed to stop sampling and resulted in taking around 5 extra samples that was not required.The vacuum button was pressed to force stop the sampling.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record and manufacturing review was not required as the device was not returned.Investigation summary: the physical device was not returned for evaluation.No photos or video were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the unintended movement 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: 09/2045), 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 a breast biopsy procedure, the device allegedly failed to stop sampling and resulted in taking around 5 extra samples that was not required.The vacuum button was pressed to force stop the sampling.There was no reported patient injury.

• Brand Name: ENCOR MRI DRIVER
• Common Device Name: REUSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15376457
• Report Number: 2020394-2022-00727
• Device Sequence Number: 5661437
• Product Code: KNW
• UDI-Device Identifier: 00801741086083
• UDI-Public: (01)00801741086083
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: DRENCORMR
• Device Catalogue Number: DRENCORMR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown