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 Patient Involvement (2645)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

The user facility reported that the needle cover did not latch.Follow up communication revealed; (1) the safety device was closed by pressing it against the exam table; (2) the nurse went to twist the syringe; (3) the needle became disengaged; and (4) the nurse incurred a needle stick.

Manufacturer Narrative

Section a was left blank because there was no patient involvement.The involved sample is not available for evaluation.Therefore, the investigation was based upon evaluation of user facility information, retained samples, and quality records.Visual inspection of retained samples did not reveal any defects or abnormalities.Function testing on the reserve samples confirmed that performance specifications were met.Simulation testing for activation of the safety device was performed using three different techniques: (1) according to the hand technique in the ifu it states, grasp the wing with your thumb on top and your index finger under the wing, activation was successful; (2) activation of the safety device with the index finger on the location of 0.5cm higher than the wing was also successful; and (3) activation of the safety device with the index finger location of 1.0cm higher than the wing was unsuccessful.A review of the device history record confirmed that there were no production related problems for this lot number.A review of the complaint files confirmed that this lot number has not been reported previously.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 grasping the wing with the index finger above the wing while activating.In doing this the index finger may be obstructed by the safety shield during activation and may cause the activation failure of 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).Device not returned.

Manufacturer Narrative

This report is being submitted as follow-up # 1 for mfg.Report # 3004102031-2014-00003 to provide the patient demographics \that were inadvertently not provided in the initial report.

Event Description

This report is being submitted as follow-up # 1 for mfg.Report # 3004102031-2014-00003 to provide the patient demographics that were inadvertently not provided in the initial report.

• 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 31001 8; CH 310018
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4224758
• MDR Text Key: 4969365
• Report Number: 3004102031-2014-00003
• 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,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014,11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 2194
• Device Lot Number: 140225B
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/29/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2014
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2014
• 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