MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH-XS / SF; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd posiflush-xs / sf leakage past stopper the following information was provided by the initial reporter: prefilled saline syringe is leaking out the sides of the inner plunger.No adverse event reported.

• Brand Name: BD POSIFLUSH-XS / SF
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19202897
• MDR Text Key: 341614478
• Report Number: 9616657-2024-00015
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/06/2024

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: 306572
• Device Lot Number: 4011152
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1