MAUDE Adverse Event Report: TERUMO MEDICAL PRODUCTS HANGZHOU SURSHIELD SAFETY WINGED BLOOD COLLECTION SET (MCKESSON)

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 investigation has yet to be completed.A follow up report will be submitted when the investigation is complete but no later than 30 days from the date that this report was sent.(b)(4).All currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending and follow-up.(b)(4).

Event Description

The user facility reported the 102-bc217512 device was a potential needle stick hazard for themselves.It was reported they are flimsy and it is difficult to close the safety cap over the needle after use.Follow-up communication from the user facility on 12/7/2015 reported the following information: it was reported the shield was not easy to flip back; the safety shield seemed flimsy when trying to close with one hand; it was reported no needle stick injuries incurred; and there was no impact to the patient.

Manufacturer Narrative

This report is being submitted as follow-up no.1 for mfg.Report # 3004102031-2015-00009 to provide the evaluation results.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 six reserved samples from each of the following lot numbers: 151007b and 151026b.Visual inspection revealed no anomalies or defects.Functional testing was conducted and confirmed to meet manufacturing specification.Dimensional testing was conducted and met manufacturer specification.Functional testing could not reproduce the reported failure.A device history review was conducted for this product code in the past three years with no relevant findings.A review of the release inspection record was conducted with no relevant findings.Incoming inspection of the outer diameter of the needles confirmed they met manufacturer specification.There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow-up no.1 for mfg.Report # 3004102031-2015-00009 to provide the evaluation results.

• Brand Name: SURSHIELD SAFETY WINGED BLOOD COLLECTION SET (MCKESSON)
• Type of Device: SAFETY WINGED BLOOD COLLECTION
• Manufacturer (Section D): TERUMO MEDICAL PRODUCTS HANGZHOU; m4-9-5, hangzhou economic &; technological development zone; hangzhou 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, NJ 08873 ; 8002837866
• MDR Report Key: 5303850
• MDR Text Key: 33682838
• Report Number: 3004102031-2015-00009
• 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,Followup
• Report Date: 12/04/2015,12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• 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
• Event Location: Other
• Date Report to Manufacturer: 12/04/2015
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1