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

Model Number	VC10140
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
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, a photo was provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that prior to a biopsy procedure, the instruction in the product labeling appeared to be small and unclear.There was no patient contact.
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, a photo was provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that prior to a biopsy procedure, the instruction in the product labeling appeared to be small and unclear.There was no patient contact.
Event or Problem Description
It was reported that prior to a biopsy procedure, the instruction in the product labeling appeared to be small and unclear.There was no patient contact.
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: the physical device was not returned for evaluation.One electronic photo was provided for review.Photo shows the label of vacora coaxial cannula where the reference catalogue number and px were highlighted separately.Per reviewing the label, it was noted that: background color is white for the label frames which is maintained, the product name; coaxial cannula is in the blue (pantone 300) which is maintained, ref catalog and symbol icon, contents and symbol, use by and symbol, lot number and symbol were in blue (pantone 300) which is maintained.As per specifications mentioned, the label provided in the photo matches.Therefore, based on the photo review, the reported device markings/labeling problem could not be confirmed as the label matches the required specifications.Therefore, the investigation for the reported device markings/labelling problem is unconfirmed based on the comparisons.A definitive root cause for the alleged device markings/labelling problem 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.The instruction for use in this product prescribed the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.H10: d4(expiry date: 01/2024), 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.

• Brand Name: VACORA
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13589749
• Report Number: 2020394-2022-00125
• Device Sequence Number: 12249703
• Product Code: KNW
• UDI-Device Identifier: 00801741079580
• UDI-Public: (01)00801741079580
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082681
• 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): 08/04/2022

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: VC10140
• Device Catalogue Number: VC10140
• Device Lot Number: HUFP1392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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