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 Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

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 there was no label on the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% carton before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "lack of labelling on a carton of bd posiflush xs syringes".

Manufacturer Narrative

H.6.Investigation: to aid in the investigation of this issue, three picture samples were provided for evaluation by our quality engineer team.Through examination of pictures, the shelf cartons were found to be missing a product information label.Based on the investigation findings, it is most likely that this incident resulted due to an intermittent issue with the vision detection system within the production environment, allowing this defective product to be released.Our quality team will closely monitor the production and packaging process for signs of this potential defect and any signs of emerging trends for this issue.Dhr could not be performed due to unknown lot#.H3 other text : see h.10.

Event Description

It was reported that there was no label on the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% carton before use.The following information was provided by the initial reporter, translated from french to english: "lack of labelling on a carton of bd posiflush xs syringes".

• 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: 10743989
• MDR Text Key: 215384874
• Report Number: 9616657-2020-00162
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1