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

Model Number	1616MS
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is (b)(4).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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 12/2024).
Event or Problem Description
It was reported that prior to a biopsy procedure, the device label was allegedly found to be missing.There was no patient contact.
Additional Manufacturer Narrative
H10: as this malfunction is considered one event; only one mdr report will be submitted for the reported quantity affected of 2 for this event.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The sample has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 12/2024).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 prior to a biopsy procedure, the device label was allegedly found to be missing.There was no patient contact.
Additional Manufacturer Narrative
H10: as this malfunction is considered one event; only one mdr report will be submitted for the reported quantity affected of 2 for this event.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: 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: two mission disposable core biopsy instrument cartons were returned to evaluation.During visual evaluation, it was noted that five devices were returned with each carton.Returned carton label matches with all the devices inside the box and the devices were in sealed condition.On further evaluation, it was noted that the carton end label was not present in the returned cartons.Therefore, the investigation is confirmed for the reported label missing information, as end carton label does not present in the returned cartons.One electronic photo was provided and reviewed.Provided photo shows the carton box side view.On further evaluation, it was noted that the carton end label was not present in the side carton box.Therefore, based on the photo review, reported label missing information can be confirmed.Hence overall the investigation is confirmed for the label missing information based on photo review and sample evaluation.A definitive root cause for the alleged missing information 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: 12/2024).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 prior to a biopsy procedure, the device label was allegedly found to be missing.There was no patient contact.

• 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: 14234067
• Report Number: 2020394-2022-00330
• Device Sequence Number: 4406704
• Product Code: KNW
• UDI-Device Identifier: 00801741096976
• UDI-Public: (01)00801741096976
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 10/06/2022

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: 1616MS
• Device Catalogue Number: 1616MS
• Device Lot Number: 0001447181
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/04/2022; 10/06/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/27/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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