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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MISSION NEEDLE; BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. MISSION NEEDLE; BIOPSY INSTRUMENT Back to Search Results
Catalog Number 1410MS
Device Problems Difficult to Remove (1528); Device Misassembled During Manufacturing /Shipping (2912); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2023
Event Type  malfunction  
Manufacturer Narrative
H10: 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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2025) 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 Description
It was reported that during an ultrasound guided breast biopsy procedure through hard density tissue, the needle was allegedly bent.It was further reported that the tissue collection failed, and tissue tear was allegedly felt.There was no reported patient injury.
 
Event Description
It was reported that during an ultrasound guided breast biopsy procedure through hard density tissue, the needle was allegedly bent.It was further reported that the tissue collection failed, and tissue tear was allegedly felt.Reportedly, the needle guard protector was not in place upon opening the package.There was no reported patient injury.
 
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: received one mission disposable core biopsy instrument for evaluation.During visual evaluation, the device appeared to be clean & received with protective tubing and the device was returned in initial position.The device was engaged to reveal the sample notch and it was noted that the sample notch was found to be bent forwards when positioned on a flat surface.No other visual anomalies were noted to the device.Further functional testing was not performed, due to the nature of complaint.Therefore, the investigation is confirmed for the reported bent needle issue as the sample notch was found to be bent.The investigation is inconclusive for the reported device misassembled during manufacturing or shipping issue as there is no evidence on how the needle protector was placed on the device.And, the investigation is inconclusive for the reported difficult to remove issue as the condition of use cannot be replicated in the laboratory.A definitive root cause for the alleged bent needle, device misassembled during manufacturing or shipping and difficult to remove issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiration date: 06/2025), g3, h6 (device, method).H11: h6 (result, conclusion).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.H3 other text : see h10.
 
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Brand Name
MISSION NEEDLE
Type of Device
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe 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 Key18577996
MDR Text Key334074023
Report Number2020394-2024-00112
Device Sequence Number1
Product Code KNW
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K171953
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1410MS
Device Lot Number0001475755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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