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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT BIOPSY NEEDLE KIT

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BOSTON SCIENTIFIC CORPORATION INTERJECT BIOPSY NEEDLE KIT Back to Search Results
Model Number M00518301
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an interject needle was opened on (b)(6) 2021. During preparation, the physician found hair contamination. It was reported that the device was not unpacked. There was no patient involvement in this case.
 
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Brand NameINTERJECT
Type of DeviceBIOPSY NEEDLE KIT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12044305
MDR Text Key257759558
Report Number3005099803-2021-02781
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K171454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00518301
Device Catalogue Number1830
Device Lot Number0026647311
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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