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

Model Number	VB14116US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an breast biopsy, the device tube allegedly detached from the device.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one vacora probe and detached syringe assembly was returned for evaluation.During visual evaluation, the sample appeared to have blood residue on the needle.The cannula was retracted thus exposing the sample notch and the syringe was detached from the tubing.Dimensional observations were done for the tubing set and syringe.The os dimensions for both tubing set and syringe were within the specified dimensions.Functional testing was not performed due to the nature of the complaint.Therefore the investigation is inconclusive for the reported tube detachment, as functional testing was not performed.Two photos were also provided and reviewed.First and second photo shows the vacora probe with tubing set detached from the syringe and blood was noticed at the connecting end of the tubing set.Therefore, based on the photo review, the reported failure tube detachment could not be confirmed on the findings no conclusion can be made.A definitive root cause for the alleged tube detachment issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g3 h11: h6 (method, result and conclusion) 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 breast biopsy procedure, the tube allegedly detached from the device.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VACORA
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11919243
• Report Number: 2020394-2021-01154
• Device Sequence Number: 804955
• Product Code: KNW
• UDI-Device Identifier: 00801741079351
• UDI-Public: (01)00801741079351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: VB14116US
• Device Catalogue Number: VB14116US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other