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 Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/27/2020

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.(b)(4).

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had black foreign matter on the tip that was noticed prior to use.The following information was provided by the initial reporter: "black noted at tip of syringe.Unsafe to use".

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 2020-08-25.H.6.Investigation summary a device history record review was performed for provided lot number 0044501 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, both picture and physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, foreign matter was identified on the tip components.It has been determined that this incident resulted from an error in the molding machine.Through examination of the molding process, burn marks were found on the tip caps manufactured within the molding machinery.The cavity of the molding machine was cleaned and polished to prevent this defect from recurring.Further action has not been determined necessary at this time.Our quality team will closely monitor the production process for signs of this potential defect.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had black foreign matter on the tip that was noticed prior to use.The following information was provided by the initial reporter: "black noted at tip of syringe.Unsafe to use".

• 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: 10418090
• MDR Text Key: 204044614
• Report Number: 9616657-2020-00124
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

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: 01/31/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0044501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other