MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER INTERJECT¿; BIOPSY NEEDLE KIT

Model Number	M00518351
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The other complaint source is (b)(6).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 or Problem Description
It was reported to boston scientific corporation that an interject¿ needle was unpacked on (b)(6) 2017.According to the complainant, while unpacking a foreign matter was noted inside the sterile pouch.There was no procedure nor patient involvement.
Additional Manufacturer Narrative
Investigation results: an interject needle was returned for analysis.A visual evaluation of the returned device found that a filament/hair was found inside the sealed pouch.The complaint of foreign matter found inside the pouch was confirmed.Based on the information available and the analysis performed, the most probable cause for the complaint event will be "manufacturing execution error¿ as the manufacturing process was not executed as validated/as designed.There is an investigation to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an interject¿ needle was unpacked on (b)(6) 2017.According to the complainant, while unpacking a foreign matter was noted inside the sterile pouch.There was no procedure nor patient involvement.

• Brand Name: INTERJECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7016100
• Report Number: 3005099803-2017-03321
• Device Sequence Number: 16586857
• Product Code: FCG
• UDI-Device Identifier: 08714729296522
• UDI-Public: 08714729296522
• Combination Product (Y/N): N
• Initial Reporter Country: TN
• PMA/510(K) Number: K012864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2019
• Device Model Number: M00518351
• Device Catalogue Number: 1835
• Device Lot Number: 19606195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: 10/15/2017
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1