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

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	05/24/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
H6: medical device problem code a1802 captures the reportable event of packaging foreign matter.H10: investigation results the returned unpackaged optiflo hemostasis catheter was analyzed, a visual evaluation was performed and a hair was observed inside the package.No other issues were noted.Based on all available information and the condition of the returned device, problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself.The investigation concluded the most probable cause is quality control deficiency.There is an investigation in place to address this issue.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem 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.

• 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: 12044305
• Report Number: 3005099803-2021-02781
• Device Sequence Number: 10987370
• Product Code: FCG
• UDI-Device Identifier: 08714729296508
• UDI-Public: 08714729296508
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 01/17/2024
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 0026647311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1