MAUDE Adverse Event Report: PRIMARY PLUMSET; IV TUBING

Device Problems Break (1069); Material Separation (1562); Chemical Spillage (2894)

Patient Problem No Information (3190)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

Iv tubing snapped and came apart at luer lock hub where the 20 cc iv flush was attached.This exposed the pt and nurse to ganciclovir.

• Brand Name: PRIMARY PLUMSET
• Type of Device: IV TUBING
• MDR Report Key: 4226453
• MDR Text Key: 5076712
• Report Number: MW5038923
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Treatment: GANCICLOVIR
• Patient Age: 62 YR
• Patient Weight: 84