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

Catalog Number 102-BC237512

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2014

Event Type  malfunction  

Event Description

The user facility reported that the safety feature did not engage following use of the device.Follow up communication revealed; (1) the safety device requires extra effort to engage the safety mechanism; (2) one particular tech incurred three needle sticks as a result of removing the protector prior to moving the safety mechanism out of the way for injection; and (3) no medical intervention was needed.

Manufacturer Narrative

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.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.Although the cause for the reported event cannot be definitively determined based on the available information, there is no indication that the event was related to a pre-existing device defect.The device labeling does address the potential for such an occurrence in the instructions-for-use with statements such as the following: "keep hands behind the needle at all times during use and disposal".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 # 1 for mfg.Report # 3004102031-2014-00002 to provide the patient demographics that was inadvertently not provided in the initial report.

Event Description

This report is being submitted as follow-up # 1 for mfg.Report # 3004102031-2014-00002 to provide the patient demographics that was inadvertently not provided in the initial report.

• 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: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 3842472
• MDR Text Key: 4655024
• Report Number: 3004102031-2014-00002
• 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: Consumer,Health Professional,User Facility,consumer,health prof
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2014,06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 102-BC237512
• Device Lot Number: 131010B
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/27/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2014
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2013
• 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