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 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The reported lot # [19p43004] was not found for the reported catalog # [306572].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% plunger would "go up" during the purging process.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from (b)(6) to english: "pre-filled syringe bd posiflush hmc xs 10 ml.Réf.# : (b)(4).Lot: 19p43004.When opening the package of pre-filled syringes, the paper tears very badly and small fragments of paper fall into the sterile field (leading to a risk of sterility defect).In addition, the fdis note at the end of the purging process that the syringe plungers go up.There is a risk that the tubing may become unsuitable and cause air to enter and a risk of gas embolism.".

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% plunger would "go up" during the purging process.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from french to english: "pre-filled syringe bd posiflush hmc xs 10 ml - réf :(b)(4) - lot: 19p43004 when opening the package of pre-filled syringes, the paper tears very badly and small fragments of paper fall into the sterile field (leading to a risk of sterility defect).In addition, the fdis note at the end of the purging process that the syringe plungers go up.There is a risk that the tubing may become unsuitable and cause air to enter and a risk of gas embolism.".

Manufacturer Narrative

H.6.Investigation: as no physical sample, picture sample, or valid lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.As a valid lot number is unknown for this incident, a device history record review cannot be completed.See h.10.

• 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: 10876651
• MDR Text Key: 217685455
• Report Number: 9616657-2020-00169
• 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: 01/04/2021

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 Catalogue Number: 306572
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1