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

Catalog Number	1816MSK
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 12/2026).The information provided 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 outer box of the device was allegedly found to be mislabeled with a different product code; however, the device within the outer box was correctly labelled.There was no patient contact.
Event or Problem Description
It was reported that prior to a biopsy procedure, the outer box of the device was allegedly found to be mislabeled with a different product code; however, the device within the outer box was correctly labelled.There was no patient contact.
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 five for this event.H10: as the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided 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 outer box of the device was allegedly found to be mislabeled with a different product code; however, the device within the outer box was correctly labelled.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 five for this event.Manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.Three electronic photos were provided and reviewed.The 1st photo shows a label information that was observed that the packaging of the reported lot indicate product code 1816msk.The 2nd photo shows a label information that was observed that the short labels of packaging of the reported lot indicate product code 1816ms instead of the correct product code 1816msk.The 3rd photo shows one carton (5 devices) which shows both front and short label.Based on the photo review, the reported device marking/labeling problem can be confirmed.Therefore, the investigation is confirmed for the reported labeling problem as the short labels of packaging of the reported lot indicate product code 1816ms instead of the correct product code 1816msk in the provide photo.A definitive root cause for the reported labelling problem issue is determined to be manufacturing related.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.End carton label: field 1 in the photo provided states "1816ms", per label, carton end, mission disposable core biopsy instrument/kit 37269677 rev.0 field 1 should state "1816msk".Field 7 in the photo states "disposable core biopsy instrument", per label, carton end, mission disposable core biopsy instrument/kit 37269677 rev.0 field 7 should state "disposable core biopsy instrument kit".Field 12 shows the incorrect gtin number per label, carton end, mission disposable core biopsy instrument/kit 37269677 rev.0.Carton label: no anomalies were noted in the photo provided per label, carton mission disposable core biopsy instrument/kit 37269678 rev.1.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: MISSION KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CAREFUSION D.R. 203 LTD.; zona franca las americas; km 22-e-1; santo domingo 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19678321
• Report Number: 2020394-2024-00975
• Device Sequence Number: 17883678
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065(11)240218(17)261228(10)0001551185
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2024

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 Catalogue Number: 1816MSK
• Device Lot Number: 0001551185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 10/03/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 08/27/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2024
• 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