MAUDE Adverse Event Report: EQUASHIELD MEDICAL LTD. EQUASHIELD LUER LOCK ADAPTER; SET, I.V. FLUID TRANSFER

Model Number REF: LL-1

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 12/23/2017

Event Type  malfunction  

Event Description

Went during bedside report, night nurse and day nurse noted a small spot of fluid leaking from chemotherapy less than 5 cm.The leaking was coming from the insertion site of primary tubing and the equashield luer lock hob.The equashield luer lock was replaced with a different adapter from new box and it seems to be working well.Devices will be returned only if manufacturers provide prepaid shipping, packaging as per dot, or pick the item up.The details in this report is the extent to which we identify medications involved or patient contact.

• Brand Name: EQUASHIELD LUER LOCK ADAPTER
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): EQUASHIELD MEDICAL LTD.
• MDR Report Key: 7181672
• MDR Text Key: 97109065
• Report Number: MW5074524
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF: LL-1
• Device Lot Number: 16-20368
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR