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

Catalog Number 102-BC257512

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The user facility reported that the device was flimsy.Follow up communication from the user facility confirmed the following; (1) the safety "flap" was not easy to place on the needle without exposing a finger to the needle; and (2) no impact to the patient.

Manufacturer Narrative

Results and conclusions: is based upon the evaluation of the 20 unused returned samples and reserve samples.The involved device was not returned, but 20 unused samples were returned by the user facility for evaluation.Therefore, the investigation was based upon evaluation of user facility information, returned unused samples and reserve samples.Visual inspection of the unused and reserve samples showed no anomaly of the winged needle, safety device, the connection status of safety device or tubing.The angle of the safety shield met manufacturing specifications by inserting the vein needle fully into the flute of the fixture with shield leaning against fixture on the unused and reserve samples.Activation of the safety shield was activated successfully using the method indicated in the ifu, and no damage was made to the teeth on the unused samples and reserve samples.A breakage resistance test was performed to confirm the tightness of the safety shield of the unused and reserve samples.After activating the safety unit, the wing needle was fixed on a jig and placed a 2.0 n weight on the front of needle tip for 15 second to determine if the safety shield would be damaged or distorted.During the breakage resistance test after activation, the needle did not spring out from the safety shield.Inspection of the teeth showed no anomaly or defects.A simulation test to verify the blood-taking function was performed on the reserved samples.(1) according to the ifu; (2) to observe whether the finger will be exposed to the winged needle when flipping the safety shield forward toward the needle; (3) take sample out of package; (4) penetrate the artificial limb with winged needle; (5) flip the safety shield forward toward needle; (6) grasp the wing with your thumb on top of the shield and you index finger under the wing and completely remove the needle from the puncture site; (7) slide our thumb forward over the shield while pinching your finger and thumb together until an audible click is heard; (8) the safety feature is visually confirmed to be activated; and (9) simulation according to the ifu was completed successfully, the finger was not exposed to the winged needle.A review of the device history record and final release inspection records confirmed that there were no production related problems for this lot number.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 simulation testing the reported issue is most consistent with the improper use of the device, trying to activate the safety device.The device labeling does address the potential for such an occurrence in the instructions-for-use with statements such as the following: "flip the safety shield forward toward needle.Grasp the wing with your thumb on top of the shield and your index finger under the wing.Completely remove the needle from the puncture site and apply digital pressure to the site using a sterile gauze pad." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending, and follow-up.(b)(4).

• 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 31001 8; 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: 4494556
• MDR Text Key: 5334530
• Report Number: 3004102031-2015-00001
• 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: 01/13/2015,02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 102-BC257512
• Device Lot Number: 131224B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Report to Manufacturer: 01/13/2015
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2013
• 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