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

Catalog Number 102-BC217512

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual sample was not returned to the manufacturing facility for evaluation and the lot # is unknown.Therefore, the investigation was based upon the user facility information and the evaluation of two reserved samples from each of the following lot numbers: 151007b, 151026b and 151228b.Visual inspection revealed no anomalies or defects.Functional testing was conducted and confirmed to meet manufacturing specification.Dimensional testing was conducted and confirmed to meet manufacturer specification.Functional testing could not reproduce the reported failure.A device history review was conducted for this product code in the past six months with no relevant findings.A review of the release inspection record was conducted with no relevant findings.(b)(4).All currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending and follow-up.Device not returned to manufacturer.

Event Description

The user facility reported "no needle safety, needle moves in use, does not retract" when using the 102-bc217512 device.Follow-up communication from the user facility on (b)(4) 2016 reported the following information: (1) it was stated "they were concerned with no needle safety that retracts"; (2) the needle moves when in the vein, so they perceive product as a whole to be "flimsy"; (3) it was reported the customer was new to this product; (4) it was stated, "they had not received any specific in-service for instructions regarding use of this product"; and (5) there was no impact to the patient.

• Brand Name: SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
• Type of Device: INTRAVASCULAR SET
• 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: 5492036
• MDR Text Key: 40133006
• Report Number: 3004102031-2016-00001
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102-BC217512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• 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
• Patient Outcome(s): Hospitalization