MAUDE Adverse Event Report: TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD. SURSHIELD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MN*SVS25B30

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  malfunction  

Event Description

Upon receipt of butterfly needles staff noted they were flimsy and the safety close apparatus was unsafe.The risk of potential needle stick was too high so product has not been used.

• Brand Name: SURSHIELD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 16303055
• MDR Text Key: 308836251
• Report Number: 16303055
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MN*SVS25B30
• Device Catalogue Number: MN*SVS25B30
• Device Lot Number: 220516B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1