MAUDE Adverse Event Report: PALL CORPORATION POSIDYNE FILTER NEONATAL INTRAVENOUS TUBING SET STERILE DISPOSABLE; FILTER, INFUSION LINE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2020

Event Type  malfunction  

Event Description

When untangling patient's iv lines, the male adaptor on the end of the iv tubing had broken into 2 pieces.There was a plastic ring sitting around the port of the hickman, but was not activating the cap.The rest of the iv tubing was in the bed with the patient.

• Brand Name: POSIDYNE FILTER NEONATAL INTRAVENOUS TUBING SET STERILE DISPOSABLE
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park dr; port washington NY 11050
• MDR Report Key: 10784927
• MDR Text Key: 214551577
• Report Number: 10784927
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1