MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL; N/A

Catalog Number 306572

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: no samples were received for investigation.There is no evidence that posiflush syringe was responsible for this infection.A potential contributory factor maybe other medicinal products in use or administered at this time.Investigation conclusion: a complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of infection with lot #9171672 regarding item #306572.Root cause description: based on the information provided, it is more probable than not that the symptoms described may be infection related; it is highly unlikely that this infection was produced as a result of the saline solution in the bd posiflush product.

Event Description

It was reported that a patient was admitted to the hospital with suspected sepsis after using bd posiflush¿ xs pre-filled flush syringe nacl.The following information was provided by the initial reporter: patient was admitted to hospital with suspected sepsis.Nurse reports arriving to connect patient and they were showing signs of sepsis: rigors, hr over 90 and temperature of 38.3.Nurse rang ambulance and patient admitted.Patient treated with iv antibiotics for sepsis of unknown origin.No cvc line cultures could be obtained.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL
• Type of Device: N/A
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9233565
• MDR Text Key: 177285296
• Report Number: 9616657-2019-00355
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9171672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention