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 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was not returned for evaluation.A retention sample of the involved product code/lot# combination was evaluated as follows.The related test such as visual inspection, the angle of the safety shield, activation of safety shield and pulling force of needle to the retained samples show no abnormities.The ifu reference states: step 1, place the safety shield over the needle after use.Step 2, press the wings together with the thumb and middle finger and press the safety shield with index finger then withdraw needle from the vein.Step 3, press the safety shield together with thumb and index finger until an audible click is heard.Step 4, discard the needle after activation.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).

Event Description

The user facility reported user that the safety scalp vein set has been locked into the protective cover (heard and saw the needle locked in place) after blood taking.Then disposed the needle but it was not fully dropped into the sharp box.The user tried to push it down by hand but then felt pain and found bleeding from the right thumb.It was found that the needle was dislodged from the protective cover.It was reported that the there was no patient involvement and the nurse that was stuck with the needle was not infected.The nurse heard the click sound but did not check the needle to ensure it was probably trapped.

• 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: 7218238
• MDR Text Key: 98415586
• Report Number: 3004102031-2018-00001
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: SV*S21BL18
• Device Lot Number: 161127B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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