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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MAGNUM CORE BIOPSY NEEDLE BIOPSY INSTRUMENT

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BARD PERIPHERAL VASCULAR, INC. BARD MAGNUM CORE BIOPSY NEEDLE BIOPSY INSTRUMENT Back to Search Results
Catalog Number MN1820
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2018
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the sample was not returned and no photos were provided for review. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any deficiency with the needle in respect to the alleged bleeding. Limited information was provided surrounding the event; therefore, a definitive root cause could not be determined based upon available information. It is unknown if patient and/or procedural factors contributed to the reported event. It should be noted that the instructions for use (ifu) provides information to mitigate the risk of product use as well as possible complications. The ifu states: "this product should be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific organ being biopsied. " additionally, ¿warnings: good medical judgment should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who have a bleeding disorder. ¿ the ifu further states: "potential complications associated with core biopsy procedures are site specific and include, but are not limited to: hematoma; hemorrhage; infection; adjacent tissue injury; pain; bleeding; hemoptysis; hemothorax; non-target tissue, organ or vessel perforation; pneumothorax; and air embolism. Air embolism is a rare but serious potential complication of lung biopsy procedures. Rapid deterioration of neurological status and/or cardiac arrhythmia may be indicative of air embolism. Prompt diagnosis and treatment must be considered if the patient exhibits signs or symptoms of air embolism. " it is unknown if other factors continued to the reported event. Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate. 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 prostate biopsy, the patient allegedly presented bleeding. The patient was reported as in serious condition.
 
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Brand NameBARD MAGNUM CORE BIOPSY NEEDLE
Type of DeviceBIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX 88780
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7603932
MDR Text Key111142693
Report Number2020394-2018-00878
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00801741084355
UDI-Public(01)00801741084355
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K934370
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberMN1820
Device Lot NumberREBQ2556
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/14/2018 Patient Sequence Number: 1
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