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

Catalog Number 306572

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Medical device lot #: an invalid lot # of 19p43004 was provided.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% experienced packaging tears while opening leaving paper shards in sterile field/room.The following information was provided by the initial reporter: pre-filled syringe bd posiflush hmc xs 10 ml, ref: 306572, 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

Investigation summary: as no physical sample, picture sample, or 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.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced packaging tears while opening leaving paper shards in sterile field/room.The following information was provided by the initial reporter: pre-filled syringe bd posiflush hmc xs 10 ml.Ref : (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.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10848248
• MDR Text Key: 219530365
• Report Number: 9616657-2020-00166
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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
• Date Manufacturer Received: 01/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1