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

Model Number	1610MSK
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As this malfunction is considered one event; only one mdr report will be submitted for the reported quantity affected of 30 for this event.The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.As the lot number for the device was provided, a review of the device history records will be performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2024).
Event or Problem Description
It was reported that prior to a biopsy procedure, the front end label of the package allegedly mismatches with box label.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 6 for this event.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: six cartons (thirty mission kits) containing sealed lot samples of mission disposable core biopsy instruments were received.Each carton contains five devices inside it.On visual evaluation, it was noted that the carton end label does not match with the information in the tw.And it was further noted that the label information of the device inside the carton was found to be matching with the tw information.Therefore , the investigation for the reported device markings/labelling problem is confirmed as there was a mismatch between the label information of the outside carton and the device present inside the carton.Three electronic photos were provided for review.First photo shows the kit label information which shows 1610msk (material no) and 0001433779 (lot no).Second photo shows the label present on the top side of the carton which states 1610msk (material no) and 0001433779 (lot no).Third photo shows the label present at rear end of the carton, which shows the label information (i.E 2010 ms and 0001431580).Therefore, based on the photo review, the reported failure device markings/labelling can be confirmed.Therefore, the investigation for the reported device markings/ labelling problem can be confirmed as there was mismatch between the information present on the label at the rear end of the carton and the label at the top side of carton , and in the outer packaging of the device present inside.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 manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.H10: d4(expiry date: 08/2024).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 procedure, the device package was allegedly mislabeled.There was no patient contact.

• Brand Name: MISSION KIT
• 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: 13520740
• Report Number: 2020394-2022-00097
• Device Sequence Number: 11801904
• Product Code: KNW
• UDI-Device Identifier: 00801741142567
• UDI-Public: (01)00801741142567
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 1610MSK
• Device Catalogue Number: 1610MSK
• Device Lot Number: 0001433779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2021
• 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