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

Catalog Number 306572

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% plunger got stuck while flushing the tubing during use, and there was "5 ml" of liquid left in the syringe.The following information was provided by the initial reporter, translated from french to english: "while rinsing a tubing, the syringe got stuck.There was 5 ml of liquid left in the syringe.The device is now available for analysis.".

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% plunger got stuck while flushing the tubing during use, and there was "5 ml" of liquid left in the syringe.The following information was provided by the initial reporter, translated from french to english: "while rinsing a tubing, the syringe got stuck.There was 5 ml of liquid left in the syringe.The device is now available for analysis.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for evaluation?: yes.D.10.Returned to manufacturer on: 9/23/2020.H.6.Investigation: a device history record review was performed for provided lot number 0118620 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, the physical sample was returned for evaluation by our quality engineer team.Through examination of the sample, 1 ml of saline was found remaining in the syringe.When the plunger rod was pressed downwards, there were no detected issues found with the movement.Based on the investigation results, an exact cause for this incident could not be determined.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10535122
• MDR Text Key: 216397602
• Report Number: 9616657-2020-00148
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0118620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other