MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR NM600/610; INJECTOR AND SHEATHSET

Model Number NM-610U-0426

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Event Description

As reported for this event by the customer, during an unknown procedure the customer had difficulty in opening the sealed package of the device.This device is sealed with an additional seal package.Since the customer had to forcibly open the package, there is a chance of contamination by contact with an unclean area.Customer is recommending that the package seal be improved for ease of opening.

Manufacturer Narrative

Additional information has been received for this event.This supplemental report is being submitted to provide this information.Please see the updates in sections: b5, g3, g6, h2, and h10.Patient information is not known.

Event Description

Though the customer complained about the difficulty in opening the device package seal, the customer was able to open the packaging and use the device in the procedure.There was no harm or adverse impact on the patient.The procedure details are not known.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4: the subject device was manufactured in may 2022.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The legal manufacturer's final investigation confirmed that the sterile packages that are additionally heat-sealed have a higher seal strength than those that are not additionally heat-sealed.Therefore, the sterile packages with additional heat sealing are difficult to open.The legal manufacturer has determined there is no potential for this malfunction to cause or contribute to an adverse event.

• Brand Name: SINGLE USE INJECTOR NM600/610
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15322163
• MDR Text Key: 305516652
• Report Number: 9614641-2022-00230
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422874
• UDI-Public: 04953170422874
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K153625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-610U-0426
• Device Lot Number: 25K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1