MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PRE-FILLED SYRINGE

Catalog Number 306572

Device Problem Component Missing (2306)

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

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was received without saline.The following information was provided by the initial reporter: "the syringe received was empty, did not contain any of the saline.".

Manufacturer Narrative

Correction: additional information was received from the customer stating the event was a miscommunication and is no longer reportable.This complaint will be cancelled.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was received without saline.The following information was provided by the initial reporter: "the syringe received was empty, did not contain any of the saline.".

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8565551
• MDR Text Key: 143709284
• Report Number: 9616657-2019-00202
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8337858
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other