MAUDE Adverse Event Report: RMS MEDICAL PRODUCTS FREEDOM60 275ML/HOUR TUBE SET; SQIG TUBING

Model Number FREEDOM60 SQIG 27ML TUBING

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2015

Event Type  malfunction  

Event Description

Mom notified our company that the freedom 60 flow rate tubing is defective.The end of the tubing (the plastic piece) that attaches to the syringe for sqig infusion comes apart.Mom states this is the second week in a row that this issue has occurred and the medication was lost/wasted with the dose last week, but this week the infusion was already finished when the end of the tubing came off.Mom states the lot# is 1.084/15 and it is the 275 ml size tubing.Our organization carries multiple sizes of this tubing, and all of the other sizes did not pull apart as easy as the 275ml.We pulled two other lot numbers of the 275ml tubing and they were easy to pull off the hard plastic piece from the tubing.Organization is in the process of changing to a different tubing set for sqig infusions.

• Brand Name: FREEDOM60 275ML/HOUR TUBE SET
• Type of Device: SQIG TUBING
• Manufacturer (Section D): RMS MEDICAL PRODUCTS; chester NY 10918
• MDR Report Key: 5201160
• MDR Text Key: 30469110
• Report Number: MW5057637
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FREEDOM60 SQIG 27ML TUBING
• Device Lot Number: 1.084/15; 1.065/15
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR