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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MISSION DISPOSABLE CORE BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. MISSION DISPOSABLE CORE BIOPSY INSTRUMENT Back to Search Results
Model Number 1816MSK
Device Problems Bent (1059); Break (1069); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation of the reported event is currently underway.(expiry date 06/2020).The information provided by bard 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 bard.
 
Event Description
It was reported that during a ct-guided lung biopsy, the coaxial introducer allegedly bent as the patient moved.Reportedly, after removing from the patient, the coaxial broke into pieces as the healthcare professional attempted to bend it into the initial shape.It was further reported that the procedure was completed with another device.There was no reported patient injury.
 
Event Description
It was reported that during a ct-guided lung biopsy, the coaxial introducer allegedly bent as the patient moved.Reportedly, after removing from the patient, the coaxial broke into pieces as the healthcare professional attempted to bend it into the initial shape.It was further reported that the procedure was completed with another device.There was no reported patient injury.
 
Manufacturer Narrative
A lot history review was conducted and it was determined that a device history record (dhr) review was not required, however requested.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.One mission needle, one coaxial, and three electronic photos were returned for evaluation.Based on the photo review, one broken coaxial can be confirmed and the reported bend could not be confirmed.The returned coaxial was received in seven segments.No other visual anomalies were noted to the returned coaxial.Functional testing could not be performed due to the returned sample condition.Therefore, based on the photo review and returned device, the investigation is confirmed for the reported break and inconclusive for the reported bend due to the returned sample condition.Although it is likely patient and procedural issues (i.E.Patient moved) contributed to the reported event, it is also likely the reported bend contributed to the reported break.However the definitive root cause could not be determined based upon the provided information.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).
 
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Brand Name
MISSION DISPOSABLE CORE BIOPSY INSTRUMENT
Type of Device
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7665349
MDR Text Key113288245
Report Number2020394-2018-01119
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00801741097065
UDI-Public(01)00801741097065
Combination Product (y/n)N
PMA/PMN Number
K133948
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1816MSK
Device Catalogue Number1816MSK
Device Lot NumberHUBU1136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2018
Date Manufacturer Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age45 YR
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