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

Model Number	M00518351
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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).Investigation results: an interject needle was received by boston scientific.The device was received in its original, sealed pouch.Visual analysis of the returned device revealed a hair inside the pouch.Additionally, it was observed that the shipping clip detached and the was needle prematurely extended within the package.No other issues were noted.It is most likely that detachment of the shipping clip occurred as result of transport/storage.Handling and manipulation of the device can cause the clip to fall off from handle which can then cause the needle to prematurely extend inside the pouch.Analysis revealed that the hair was found caught on the heat seal area of the pouch.Based on the information available and the analysis performed, the most probable cause of the reported event is manufacturing deficiency, due to problems traced to manufacturing process.There is an investigation to address this issue.
Event or Problem 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.

• Brand Name: INTERJECT
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8511583
• Report Number: 3005099803-2019-01524
• Device Sequence Number: 1962767
• Product Code: FCG
• UDI-Device Identifier: 08714729296522
• UDI-Public: 08714729296522
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K171454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 11/01/2021
• Device Model Number: M00518351
• Device Catalogue Number: 1835
• Device Lot Number: 0022883472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 09/25/2019
• Patient Sequence Number: 1