MAUDE Adverse Event Report: BD POSIFLUSH INJECTABLE SALINE SYRINGE 10ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306533

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 04/25/2018

Event Type  malfunction  

Event Description

Reporter called from uf to report a product problem with posiflush injectable saline syringe 10ml.Reporter believes this device needs to be recalled.Reporter stated she received 2 cases of the device within lot # 7180928 with brown spots and the product should be sterile.Reporter said the devices cannot be used.

• Brand Name: POSIFLUSH INJECTABLE SALINE SYRINGE 10ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 7464085
• MDR Text Key: 106837594
• Report Number: MW5076746
• Device Sequence Number: 2
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 306533
• Device Lot Number: 7180928
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR