MAUDE Adverse Event Report: TERUMO MEDICAL PRODUCTS HANGZHOU PREVENT SAFETY WINGED BLOOD COLLECTION SET (PSS); SAFETY NEEDLE

Catalog Number 2194

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The user facility reported the safety mechanism was inconsistent.Follow up communication from the user facility confirmed the following; (1) was anticipating a needle stick; (2) no needle stick occurred; and (3) no impact to the patient.

Manufacturer Narrative

Due to the unknown lot # the investigated lots are as follows: 140213b, 140225b, 140305b, 140312b, 140416b, 140520b and 140614.The actual sample has not been returned to the manufacturing facility for evaluation and the lot # is unknown.Therefore, the investigation was based upon the user facility information and the evaluation of reserve samples from three random lots (140213b, 140312b, 140520b).Visual inspection revealed no abnormity.A penetration resistance test was performed and confirmed to manufacturer specifications.The needle's rigidity was tested and met manufacturer specifications.Testing toughness of needle was conducted and confirmed the needle did not break off.No abnormity was found.The angle of the safety shield was inspected and met manufacture specifications.Activation of safety shield was activated using the method indicated in the ifu.The safety unit was successfully activated and no tooth was damaged was revealed.A breakage resistance test after activation of the safety unit confirmed the needle did not spring out from the safety shield.Meanwhile, the teeth's status was checked, no abnormity of teeth damage or distortion was found.A review of the device history record and the release inspection records confirmed that there were no production related problems for the involved product code manufactured from february to july of 2014.(no product manufactured for the month of july 2014).There is no evidence that this event was related to a device defect or malfunction.Although the cause for the reported event cannot be definitively determined based on the available information from the user facility and the evaluation of the reserve samples from three random lots, the results revealed that the performance of our products conform to the performance requirement during normal use.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending, and follow-up.(b)(4).Device not returned to manufacturer.

• Brand Name: PREVENT SAFETY WINGED BLOOD COLLECTION SET (PSS)
• Type of Device: SAFETY NEEDLE
• Manufacturer (Section D): TERUMO MEDICAL PRODUCTS HANGZHOU; m4-9-5, hangzhou economic &; technological development zone; hangzhou, china 3100 18; CH 310018
• Manufacturer (Section G): TERUMO MEDICAL PRODUCTS HANGZHOU; m4-9-5, hangzhou economic &; technological development zone; hangzhou, china 3100 18; CH 310018
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4598222
• MDR Text Key: 5628948
• Report Number: 3004102031-2015-00003
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2015,03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Report to Manufacturer: 02/19/2015
• Date Manufacturer Received: 02/19/2015
• 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