MAUDE Adverse Event Report: BD BD POSIFLUSH NORMAL SALINE SYRINGE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 306546

Device Problem Difficult to Flush (1251)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2023

Event Type  malfunction  

Event Description

Bd saline flushes (ref (b)(4)) with lot # 2227080 are not working properly.User cannot flush entire syringe of saline.Something stops the user from injecting the entire syringe of saline.

• Brand Name: BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 16502645
• MDR Text Key: 310969193
• Report Number: MW5115522
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 03/02/2023

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: Health Professional
• Device Catalogue Number: 306546
• Device Lot Number: 2227080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1