MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU WINGED INFUSION; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

Udi - not required until 09/2016.The actual device was not returned to the manufacturing facility for evaluation and the product code and lot number are unknown.A review of the manufacturing inspection records for the past three years was conducted with no relevant findings.(b)(4).All available information has been placed on file in quality assurance for tracking, trending, and follow up.Device not returned to manufacturer.

Event Description

A search of the fda's maude database on april 19, 2015 found medwatch report # mw5061247 that states the following: "client reported that she found 2 butterfly needles in her inventory that she could not remove the protective tube from the tip of the needle." please see the attached maude report for your reference, including the fda medwatch report no.Mw5061247 for this event.Please see mdr report no.9681835-2016-00013 for the second device reported.

• Brand Name: WINGED INFUSION
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 583; JA 409-3583
• Manufacturer (Section G): TERUMO CORPORATION - KOFU; reg. no. 9681835; 1727-1, tsuiji-arai, showa-cho; nakakoma-gun, yamanashi 409-3 583; JA 409-3583
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5659521
• MDR Text Key: 45314553
• Report Number: 9681835-2016-00014
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K771204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2016
• 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