MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MISSION 20GX10CM NEEDLE; BIOPSY INSTRUMENT

Model Number	2010MS
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a biopsy procedure, the labels in the product and the package were allegedly mismatching.There was no patient contact.
Additional Manufacturer Narrative
As this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of forty for this event.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 device has been returned to the manufacturer for evaluation as well as photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 08/2024).As the lot number for the device was provided, a review of the device history records is currently being performed.The device (has or has not) been returned to the manufacturer for evaluation.However, photos/images/videos were provided for review.The investigation of the reported event is currently underway.
Additional Manufacturer Narrative
H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of eight 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: three electronic photos were provided for review.First photo shows the rear end of the carton where there is a label which states 2016ms(material no) and 0001434060 (lot number).Second photo shows the label present on the top side of the carton which states 2010ms (material no) and 0001431580 (lot number).Third photo shows both the label present at the top end of the carton and the outer packaging of the device present inside the carton, where both are matching(i.E 2010 ms and 0001431580).Therefore, based on the photo review, the reported failure device markings/labelling can be confirmed.Eight cartons 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.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.H10: d4 (expiration date: 08/2024).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.
Event or Problem Description
It was reported that prior to a biopsy procedure, the labels in the product and the package were allegedly mismatching.There was no patient contact.

• Brand Name: MISSION 20GX10CM NEEDLE
• 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: 13860685
• Report Number: 2020394-2022-00202
• Device Sequence Number: 4520343
• Product Code: KNW
• UDI-Device Identifier: 00801741097027
• UDI-Public: (01)00801741097027
• 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: 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: 2010MS
• Device Catalogue Number: 2010MS
• Device Lot Number: 0001431580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/20/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown