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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 M00518351
Device Problems Device Contaminated During Manufacture or Shipping (2969); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Patient Involvement (2645)
Event Date 03/01/2019
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown. The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event. (b)(4). Although expected, the device has not been received for analysis. Upon receipt and 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 received and a hair was found inside the sterile package. There was no patient involvement with this event. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
 
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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 Key8511583
MDR Text Key141913734
Report Number3005099803-2019-01524
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K171454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2021
Device Model NumberM00518351
Device Catalogue Number1835
Device Lot Number0022883472
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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