MAUDE Adverse Event Report: TERUMO MEDICAL PRODUCTS HANGZHOU SURSHIELD WINGED INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number SV-S22EL

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device was not returned to the manufacturing facility for evaluation, however, the facility returned an unused sample for evaluation.Therefore the investigation results are based upon the user facility information, the unused sample and the evaluation of the retention samples from the reported product code/lot# combination.Visual inspection revealed no defects.Dimensional testing was conducted and confirmed the samples met manufacturer specification.Functional testing could not reproduce the reported failure.A review of the complaint records for the past two years was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined based on the available information from the user facility and investigation results.(b)(4).All currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending and follow-up.Actual device not returned.

Event Description

The user facility reported a nurse incurred a needle stick using the sv-s22el device.Follow-up communication from the user facility reported the following information: on (b)(6) 2016 it was reported that a nurse was activating the safety device and her finger slipped to the needle tip and incurred a needle stick; it was reported that the involved device was used on a patient before her injury; the nurse is under observation.Additional information was reported on june 1st 2016: it was reported that the nurse did not operate the device in accordance with the ifu, which caused the needle stick.It was reported that the nurse was not infected.

• Brand Name: SURSHIELD WINGED INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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; reg. no. 3004102031; m4-9-5, hangzhou economic &; technological development zone, hangzhou 31001 8; CH 310018
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset 08873 ; 8002837866
• MDR Report Key: 5719890
• MDR Text Key: 47209381
• Report Number: 3004102031-2016-00003
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: SV-S22EL
• Device Lot Number: 160123A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2016
• 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