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

Catalog Number 1SV*S23BL

Device Problems Device Issue (2379); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for this product code/lot number combination.The actual device was not returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.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 surshield winged infusion set.Follow up communication with the user facility confirmed the following information: the lab tech used the product on the patient and noticed while deploying the safety device it was split down the middle; the device was disposed of in a sharps container; prior to this incident two of the techs were stuck with a needle; and the tech indicated it may have been the glove that caused the safety device to grab the excess of the glove; and all lab tech went to the er to get checked out, but came back to work after.

Manufacturer Narrative

This report is being submitted as follow up no.To provide the retention sample evaluation results.The actual device has not been returned to the manufacturing facility.Therefore, the investigation is based on the user facility information and evaluation of retention samples from the reported product code/lot number combination.Visual inspection revealed no defects.The angle of the safety shield was evaluated and confirmed to meet manufacturer specification.The safety unit was successfully activated, and revealed no damage had been made.Breakage resistance test was conducted and revealed no defects.Functional testing was conducted and could not reproduce the reported defect.A review of the manufacturing record of the product code/lot# combination was conducted with no relevant findings.A review of the complaint record for the last two years was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the device return date and the returned sample evaluation results.The actual device was not returned to the manufacturing facility for evaluation, however, 38 unused samples were returned for evaluation.Therefore, the investigation was based on the evaluation of user facility information and evaluation of retention samples and 38 unused samples from the reported product code/lot number combination.Visual inspection of the retention samples revealed no defects.The angle of the safety shield was inspected and confirmed to meet manufacture specification.Activation of safety shield was conducted successfully and revealed no defects.Visual inspection of the retuned unused samples revealed no defects.The angle of the safety shield was inspected and confirmed to meet manufacture specification.Activation of safety shield was conducted successfully and revealed no defects.Specification.Function testing was conducted on both retention samples and on the returned unused samples and could not reproduce the reported defect.A review of the inspection records of the involved product/lot# combination confirmed that there were no relevant findings.A search of the complaint record for the past two years found no other complaints.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: SURSHIELD WINGED INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 6574175
• MDR Text Key: 75418661
• Report Number: 3004102031-2017-00003
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031266
• 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,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1SV*S23BL
• Device Lot Number: 160827B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2016
• 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