MAUDE Adverse Event Report: SB-KAWASUMI LABORATORIES, INC. K-SHIELD WINGED COLLECTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number DBMS-23G

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2023

Event Type  Injury  

Event Description

Loose needle on winged blood collection set.Butterfly luer set.

• Brand Name: K-SHIELD WINGED COLLECTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SB-KAWASUMI LABORATORIES, INC.
• MDR Report Key: 17127555
• MDR Text Key: 317220574
• Report Number: MW5118372
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBMS-23G
• Device Lot Number: 221216P4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention