MAUDE Adverse Event Report: WUXI YUSHOU MEDICAL; SYRINGE - 60CC LUER LOCK

Catalog Number 300-60LL

Device Problem Crack (1135)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Event Description

The syringe had a crack resulting in the resident getting splashed in the face while conducting a bedside paracentesis.The report number is mw5065084.

• Type of Device: SYRINGE - 60CC LUER LOCK
• Manufacturer (Section D): WUXI YUSHOU MEDICAL; jiangsu, wuxi, binhu, xishen r; jiangsu, china ; CH
• MDR Report Key: 7286006
• MDR Text Key: 100579717
• Report Number: 3000210101-2018-00006
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300-60LL
• Device Lot Number: 13-7818-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2015
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 59