MAUDE Adverse Event Report: TERUMO MEDICAL PRODUCTS HANGZHOU SURSHIELD SAFETY WINGED BLOOD COLLECTION SET; SAFETY NEEDLE

Catalog Number 1MN*SVS23B18

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

The user facility reported that the end-users were not activating the safety mechanism as educated resulting in needle stick injuries.Follow up communication from the user facility confirmed the following: there was no fault with the product but a resistance to using the product properly; it was reported the facility had received in service training on the device; the end user was manipulating against the ifu, and training provided, resulting in needle stick; and it was reported no medical intervention or follow up treatment required.

Manufacturer Narrative

The investigation has yet to be completed.A follow up will be sent within 30 days of this report being sent.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending, and follow-up.(b)(4).

Manufacturer Narrative

This report is being submitted as follow-up # 2 for mfg.Report #3004102031-2015-00005 to provide the patient demographics that were inadvertently not provided in the initial report.

Event Description

This report is being submitted as follow-up # 2 for mfg.Report #3004102031-2015-00005 to provide the patient demographics that were inadvertently not provided in the initial report.

Manufacturer Narrative

This report is being submitted as follow-up #1 for mfr.Report # 3004102031-2015-00005 to provide the retention sample evaluation results.The actual device was not returned to the manufacturer for evaluation and the lot is unknown, which limits the investigation to the information provided by the user facility and evaluation of the retained samples of the involved product code.The following lot numbers of product code mn*svs23b18 that were manufactured during the half past year (jan.2015~jun.2015): 150102b, 150124b, 150417b, 150418b and 150612b were evaluated.Visual inspection revealed no defects.The angle of the safety shield was inspected and met manufacturer specifications.Activation of the safety shield was activated successfully using the method indicated in the ifu with no abnormity.Breakage resistance test after activation of the safety unit revealed no abnormality.A simulation test was performed to verify the blood-taking function and observe whether the finger will be exposed to the winged needle performed according to the ifu.It was confirmed when the safety shield is flipped forward to the needle during the normal operation, the needle is still under the penetration status.Operating the device according to the ifu, the finger will not be exposed to the winged needle.A review of the manufacture records and inspection records during the past half year (jan.2015~ jun.2015) confirmed that there was no production related problems.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined based on the available information, the investigation results confirm that the performance of the retention samples conformed to the performance requirements during normal use.All currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending and follow-up.Device not returned to the manufacturer.

Event Description

This report is being submitted as follow-up #1 for mfr.Report # 3004102031-2015-00005 to provide the retention sample evaluation results.

• Brand Name: SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
• Type of Device: SAFETY NEEDLE
• Manufacturer (Section D): TERUMO MEDICAL PRODUCTS HANGZHOU; m4-9-5, hangzhou economic &; technological development zone; hangzhou, china 31001 8; CH 310018
• Manufacturer (Section G): TERUMO MEDICAL PRODUCTS HANGZHOU; m4-9-5, hangzhou economic &; technological development zone; hangzhou, china 31001 8; CH 310018
• Manufacturer Contact: kathleen little ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4899695
• MDR Text Key: 20725115
• Report Number: 3004102031-2015-00005
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2015,07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1MN*SVS23B18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2015
• Date Manufacturer Received: 06/12/2015
• 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
• Patient Age: 53 YR