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

Model Number SV*S25BL

Device Problems Fail-Safe Problem (2936); Material Integrity Problem (2978)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/27/2022

Event Type  malfunction  

Event Description

Temporary butterfly device used in lab for blood collection has a very flimsy safety device that caused an employee needle stick.She was collecting blood in a very high stress environment as the patient was bleeding out.She collected the blood, then closed the very flimsy safety device over the used needle, she did hear it click as we have been emphasizing the importance of being extremely careful with these devices.She then quickly grabbed her used supplies that were still on the bed at the patient's side as many people were in the room and they were getting ready to slide a gurney board under the patient.Upon grabbing the supplies she felt the needle penetrate the palm of her hand.

• Brand Name: SURSHIELD WINGED INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 15437426
• MDR Text Key: 300056707
• Report Number: 15437426
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SV*S25BL
• Device Catalogue Number: SV*S25BL
• Device Lot Number: 21090BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2022
• Date Report to Manufacturer: 09/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Sex: Female