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 Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 printed scale on the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was misaligned.The following information was provided by the initial reporter, translated from (b)(6) to english: "with corpuscles inside the packaging / on the body of the syringe".

Manufacturer Narrative

H.6.Investigation: the returned sample was inspected, and the defect of barrel label can be confirmed.The root cause is as a result of possible equipment fail, causing defect of the label attached to the barrel.The product was probably not rejected as the vision system.The part could have passed the 100% automated vision inspection due to possible manual intervention prior to this happening.

Event Description

It was reported that the printed scale on the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was misaligned.The following information was provided by the initial reporter, translated from italian to english: "with corpuscles inside the packaging / on the body of the syringe.".

• 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: 10927985
• MDR Text Key: 221299647
• Report Number: 9616657-2020-00170
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0118620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1