MAUDE Adverse Event Report: BD BD POSIFLUSH; 0.9 PERCENT SODIUM CHRLOIDE INJECTION

Catalog Number REF 306547

Device Problems Detachment Of Device Component (1104); Connection Problem (2900); Mechanics Altered (2984)

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

Event Date 11/08/2016

Event Type  malfunction  

Event Description

The 10 cc saline lock syringes not holding a light luer lock.Unscrewing themselves spontaneously and falling off.Batch of 20 iv start kits made with 10 cc saline syringes and connector tubing and 4 disconnected themselves spontaneously.Had been occurring rarely over the last few months, but occurring more frequently as of late.Dose or amount: 10 ml millilitres.Frequency: as needed.Route: intravenous (not otherwise specified).Diagnosis or reason for use: iv flush.

• Brand Name: BD POSIFLUSH
• Type of Device: 0.9 PERCENT SODIUM CHRLOIDE INJECTION
• Manufacturer (Section D): BD
• MDR Report Key: 6102191
• MDR Text Key: 60024090
• Report Number: MW5066017
• Device Sequence Number: 4
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/11/2016
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: REF 306547
• Device Lot Number: 6217634
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1