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

Model Number SN22G351

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 220248360
• Report Number: 1058382-2020-00003
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00386120006758
• UDI-Public: 00386120006758
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: SN22G351
• Device Catalogue Number: SN22G351
• Device Lot Number: 1903758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2020
• Distributor Facility Aware Date: 11/04/2020
• Device Age: 12 MO
• Event Location: Other
• Date Report to Manufacturer: 11/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1