MAUDE Adverse Event Report: JIANGSU SHENLI MEDICAL PRODUCTION FACTORY; SYRINGE - 30CC LUER LOCK

Catalog Number SYS35030LL

Device Problem Crack (1135)

Patient Problem Chemical Exposure (2570)

Event Date 05/10/2017

Event Type  Injury  

Event Description

A technician was sprayed in the face with alcohol and detergent when using the cracked syringe.This was submitted by (b)(6) on sept.05, 2017 to the fda.He was advised to resubmit using emdr once the account is set up.

• Type of Device: SYRINGE - 30CC LUER LOCK
• Manufacturer (Section D): JIANGSU SHENLI MEDICAL PRODUCTION FACTORY; changjiao hwy, wujin, changzho; jiangsu sheng, china 21311 1; CH 213111
• MDR Report Key: 7281201
• MDR Text Key: 100417009
• Report Number: 3000210101-2018-00003
• 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
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SYS35030LL
• Device Lot Number: 16-1040-1
• 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: 09/05/2017
• Distributor Facility Aware Date: 05/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2017
• 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