MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE SYSTM; REUSABLE BIOPSY

Model Number	E4115
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device began taking samples without any button pushed.There was no reported patient injury.
Additional Manufacturer Narrative
As the serial number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 12/2099).
Event or Problem Description
It was reported that the device began taking samples without any button pushed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record and manufacturing review was not required as the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the encor enspire breast biopsy system was received at the bd-bard global service & repair.The encor enspire breast biopsy system was visually inspected upon receipt and was found to be in poor physical condition.Also, the pin on the top of the monitor arm is sticking when pressing it down and does not secure the riser tube, the small allen screw holding the monitor arm is broken inside of the riser tube, the tray and panels have chipped paint, the right-side panel is broken at the screw hole in the front of the panel and does not secure the panel to the unit, the right-side panel is missing a screw, the rinse pivot is nicked and interfering with the vent plunger, the rinse, vent, and vacuum plunger tips are worn and have saline residue, te rinse, vent, and vacuum bushings are worn and out of round, the silicone tubing is discolored, the cartridge filter is dirty and the manufacturers serial label is not the current revision were found.The device was functionally tested and passed the test as the device operated properly without self-activating.No other anomalies were identified.Therefore, investigation is determined to be unconfirmed for the reported unintended movement issue.The root cause the reported unintended movement issue cannot be determined as the problem could not be reproduced.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: 12/2099), 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.

• Brand Name: ENCOR ENSPIRE SYSTM
• 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: 14447028
• Report Number: 2020394-2022-00383
• Device Sequence Number: 4310761
• Product Code: KNW
• UDI-Device Identifier: 00801741086113
• UDI-Public: (01)00801741086113
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K111100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: E4115
• Device Catalogue Number: E4115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/21/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female