MAUDE Adverse Event Report: PALL INTERNATIONAL SÀRL PALL PHARMASSURE SYRINGE FILTER; SYRINGE, PISTON

Model Number HP1002

Device Problem Crack (1135)

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

Event Date 02/16/2020

Event Type  malfunction  

Event Description

Filter was on iv tubing running amiodarone.Nurse states the filter was cracked.It appears to be an ongoing problem.Manufacturer response for pall pharmassure syringe filter, pall pharmassure 25 mm syringe filter (per site reporter).Nothing yet.

• Brand Name: PALL PHARMASSURE SYRINGE FILTER
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): PALL INTERNATIONAL SÀRL; 25 harbor park dr; port washington NY 11050
• MDR Report Key: 9882456
• MDR Text Key: 185051218
• Report Number: 9882456
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/25/2020

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: No Information
• Device Model Number: HP1002
• Device Catalogue Number: HP1002
• 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: 02/25/2020
• Date Report to Manufacturer: 03/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA