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

Model Number N/A

Device Problem Device Issue (2379)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned for evaluation.Therefore, the investigation was based on the user facility information and photos provided by the user facility.On (b)(6) 2017, we received pictures of actual sample.The pictures showed the safety device could be successfully activated and the needle could be locked into the safety cover and the teeth within the safety cover were intact without damage.No abnormities were observed on the actual device.Related tests, such as visual inspection, the angle of the safety shield, activation of safety shield, breakage resistance test after activation of safety unit and simulation test to the retained samples show no abnormities.A review of the manufacture record and release inspection record of the involved product code/lot number combination revealed no relevant findings.A search of the complaint file found one previous report of this nature within the last two years.See mdr number 3004102031-2016-00003.There is no evidence that this event was related to a device defect or malfunction.With no return of the actual device the exact cause of the reported event cannot be definitively determined.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a needle stick with the involved device.Follow up communication with the user facility confirmed the following information: the nurse withdrew the needle after infusion and activated the safety device to locked it into the shield; the nurse placed the infusion set on the i.V.Drip stand to stanch the bleeding; after stanching the bleeding the nurse incurred a needle stick; the nurse reported the "click" sound for activating the safety cover was felt; the head nurse reported the safety cover was activated upon receiving the sample; and the nurse received medical treatment.

• Brand Name: SAFETY WINGED INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TERUMO MEDICAL PRODUCTS HANGZHOU; m4-9-5, hangzhou economic &; technological, development zon; hangzhou, 31001 8; CH 310018
• Manufacturer (Section G): TERUMO MEDICAL PRODUCT HANGZHOU; m4-9-5, hangzhou economic &; technological development zone; hangzhou, reg. no. 3004102031 31001 8; CH 310018
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6833478
• MDR Text Key: 84075529
• Report Number: 3004102031-2017-00007
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: SV-S22BL
• Device Lot Number: 170418A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• 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
• Patient Outcome(s): Other; Required Intervention