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

Model Number	M00518301
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
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.Device code a1802 captures the reportable event of packaging foreign matter.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was intended to be used during a procedure on an unknown date.Prior to the procedure, it was noted that the device contained one hair inside the sterile packaging.No known patient complications were reported as a result of this event.At this time, boston scientific has been unable to obtain additional information despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was intended to be used during a procedure on an unknown date.Prior to the procedure, it was noted that the device contained one hair inside the sterile packaging.No known patient complications were reported as a result of this event.At this time, boston scientific has been unable to obtain additional information despite good faith efforts.
Additional Manufacturer Narrative
Block b3: 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.Block h6: device code a1802 captures the reportable event of packaging foreign matter.Investigation summary: the returned interject - sclerotherapy needles was analyzed, and a visual inspection observed a hair inside the sealed pouch.Photos were provided by the customer as well, which showed there was a foreign material in the pouch of the device.Therefore, the reported event of packaging foreign matter is confirmed.Based on all available information, this investigation is assigned a most probable conclusion code of 'quality control deficiency' because a foreign material was found inside the packaging.This issue was escalated with the operations team to confirm the failure.The manufacturing instructions for product builders require them to inspect the assembly for foreign material according to the cosmetic inspection procedure.If any foreign material is found, the assembly is to be scrapped.Additionally, they are required to inspect the pouch for foreign material and discard it if any is found.It is believed that the manufacturing process has appropriate controls to prevent or minimize such nonconformances.It should be noted that bsc spencer no longer manufactures interject devices as of april 2023.Since this is the only reported instance of foreign material in the pouch from batch 30274816, it is considered an isolated event, and no further action is required.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: INTERJECT
• Common Device Name: BIOPSY NEEDLE
• 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 Key: 16405844
• Report Number: 3005099803-2023-00664
• Device Sequence Number: 5898556
• Product Code: FCG
• UDI-Device Identifier: 08714729296508
• UDI-Public: 08714729296508
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: BR
• PMA/510(K) Number: K171454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 10/03/2025
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 0030274816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown