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 03/26/2020

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.

Event Description

It was reported before use the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had foreign matter in syringe or any fluid path component.This event occurred 3 times.The following information was provided by the initial reporter: ¿foreign matter inside the blister".

Manufacturer Narrative

Investigation summary a device history record review was performed for provided lot number 9239399 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 physical and picture samples were provided for evaluation by our quality engineer team.Through examination of the samples, foreign matter was observed within the product packaging, on the syringe product.It was been determined that this foreign matter was introduced through the molding machinery within the manufacturing facility.The molding machine was inspected and several components were replaced in an attempt to prevent this defect from recurring in the future.Our quality team will continue to monitor the production process for signs of this potential defect.

Event Description

It was reported before use the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had foreign matter in syringe or any fluid path component.This event occurred 3 times.The following information was provided by the initial reporter: ¿foreign matter inside the blister".

• 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: 9970056
• MDR Text Key: 202373405
• Report Number: 9616657-2020-00058
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9239399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other