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

Model Number	SN22G351
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are moving to close this complaint based on the manufacturer's investigation results.Although the suspect device was not returned by the end-user for examination, 20 samples from the same sterile lot were sent from retains for the factory to examine and test.Physical testing of the returned samples was performed for pull-out strength of the needle to needle hub bond, and the test samples met all specifications.In addition to the physical testing, a review of all records was conducted and no failures during production were reported.A copy of the test report will be filed with the fda to close the mdr report filed for this issue.Without an examination of the suspect device, the factory was unable to determine a root cause, and no corrective action will be implemented at this time.No similar complaints have been received within the past 12 months reviewed.We will continue to monitor our feedback system and take any additional action as necessary.We consider this report closed.
Event or Problem Description
It was reported by the physician that the needle disconnected from the hub during a pelvis injection and was left in the patient.It was also reported this occured three (3) times and he has used these needles previously.He did state the area in the pelvis required him to push hard into the patient because it was a narrow injection area and when he pulled the needle out it disconnected.All three patients were reported to be moderately obese.

• Brand Name: RELI
• Common Device Name: ANESTHESIA NEEDLE
• Manufacturer (Section D): DR. JAPAN CO., LTD.; 4-15-1 nagano; gyoda city, saitama 361-0 ; JA 361-0
• MDR Report Key: 10950317
• Report Number: 1058382-2020-00003
• Device Sequence Number: 19887220
• Product Code: BSP
• UDI-Device Identifier: 00386120006758
• UDI-Public: 00386120006758
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2020
• Report Date (Section F): 12/04/2020

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: 11/21/2024
• Device Model Number: SN22G351
• Device Catalogue Number: SN22G351
• Device Lot Number: 1903758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2020
• Device Age: 12 MO
• Event Location: Other
• Date Report to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/04/2020