MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ SP; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306574

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2020

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 that 2 bd posiflush¿ sp syringes didn't come with a product insert.This was noticed before use.The following information was provided by the initial reporter: "no leaflet".

Manufacturer Narrative

H.6.Investigation:a device history record review was performed for provided lot number 9213637 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 incident, picture samples were provided for evaluation by our quality team.Through examination of the pictures, the shelf carton was observed missing the product insert.To further investigation this incident, our quality team obtained two retained sample shelf cartons of the same lot number from the manufacturing facility.Both of the retained shelf cartons contained the product insert.It has been determined that this incident resulted from a failure in the weight detection system, which ensures the proper product and insert count, and a failure in the packaging station.Due to the current strict preventive measures in place, we believe this was an isolated incident with an unlikely recurrence.

Event Description

It was reported that 2 bd posiflush¿ sp syringes didn't come with a product insert.This was noticed before use.The following information was provided by the initial reporter: "no leaflet".

• Brand Name: BD POSIFLUSH¿ SP
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 10049386
• MDR Text Key: 194199442
• Report Number: 3002682307-2020-00153
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 306574
• Device Lot Number: 9213637
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other