MAUDE Adverse Event Report: INTERNATIONAL MEDISURG CONNECTION INC. SYRINGE - 5CC LUER LOCK

Catalog Number 300-05LL

Device Problem Crack (1135)

Patient Problem Chemical Exposure (2570)

Event Date 06/23/2016

Event Type  malfunction  

Event Description

The syringe had a crack resulting in the physician getting sprayed in the eye with a saline solution (went under the goggles).

• Brand Name: SYRINGE - 5CC LUER LOCK
• Type of Device: SYRINGE - 5CC LUER LOCK
• Manufacturer (Section D): INTERNATIONAL MEDISURG CONNECTION INC.; 935 n. plum grove rd ; ste f; schaumburg IL 60173
• MDR Report Key: 5986601
• MDR Text Key: 56014739
• Report Number: MW5065083
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300-05LL
• Device Lot Number: 13-7814-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1