MAUDE Adverse Event Report: DR. JAPAN CO. LTD. ACCUTIP; ANESTHESIA NEEDLE

Catalog Number	CP-AT2235Q
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the doctor was using a 22g x 3 ½" quincke needle for a sacroiliac joint injection and when she went to remove the needle from the patient the plastic hub separated from the metal needle.An incision was made to remove the needle from the patient as the needle was inserted underneath the surface of the skin.
Event or Problem Description
It was reported the doctor was using a 22g x 3 ½" quincke needle for a sacroiliac joint injection and when she went to remove the needle from the patient the plastic hub separated from the metal needle.An incision was made to remove the needle from the patient as the needle was inserted underneath the surface of the skin.
Additional Manufacturer Narrative
Manufacturer narrative: investigation result: after examining the actual device returned by the end-user, it was observed the needle cannula was bent in several locations, and there multiple substances attached.A large scratch was observed on the cannula which may have been caused when the needle was removed from the patient.It was observed that the hole in the needle hub from which the needle was attached was circular and no abnormality was found.There was an unidentified substance inside the needle hub at the attachment site, but as the needle shape remains it may have been caused after the needle was removed.The investigation was unable to identify a root cause for the needle separation by examining the returned device.Batch records were checked for the same lot and the product lot passed the final inspection pulling test.There were no other complaints reported for this issue for this lot number.There have been no similar complaints reported for this device family for the past three (3) years.As no root cause was determined, no corrective action will be taken.The investigation report is attached to this report for reference.We consider this file closed.Corrected data: section d10: device returned to the manufacturer date added.Section f7: supplemental report 001 selected.Section h10: narrative and corrected data added.Factory investigation report with attachments added to file.

• Brand Name: ACCUTIP
• Common Device Name: ANESTHESIA NEEDLE
• Manufacturer (Section D): DR. JAPAN CO. LTD.; 1-1 kagurazaka, shinjuku-ku; tokyo, 162-0 825; JA 162-0825
• MDR Report Key: 9252431
• Report Number: 1058382-2019-00006
• Device Sequence Number: 16735114
• Product Code: BSP
• UDI-Device Identifier: 00817781020079
• UDI-Public: 817781020079
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019
• Report Date (Section F): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2023
• Device Catalogue Number: CP-AT2235Q
• Device Lot Number: LN-81207L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/04/2019
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 10/29/2019