MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PRE-FILLED SYRINGE

Catalog Number 306572

Device Problem Scratched Material (3020)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 after twisting off the cap, jagged edges causing plastic particles to fall off were found on the area of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% that inserted directly into the "bung" on the patient's picc line.The following information was provided by the initial reporter: "it was reported that a patients mother advised there were multiple 'jagged edges' on bd posiflush xs (b)(4) used for her home iv's (pre & post infusion).When she twisted off the cap, the area at the tip of the syringe contained the jagged edge, this area is inserted directly into the bung on patients picc line.This was causing plastic particles to fall off.The patients mother has two boxes of flushes at her home and advised the issue was consistent with both boxes - some worse than others.".

Manufacturer Narrative

H.6.Investigation: dhr was performed, the non-conformances were reviewed for this batch, and there was no record of any non-conformances associated with this issue.The sample received was reviewed and confirmed barrel luer tip flash.The root cause may be related to moulding pin wear and inspection and detection methodology inadequacy on the moulding machine.Capa#733763 was initiated.

Event Description

It was reported that after twisting off the cap, jagged edges causing plastic particles to fall off were found on the area of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% that inserted directly into the "bung" on the patient's picc line.The following information was provided by the initial reporter: "it was reported that a patients mother advised there were multiple 'jagged edges' on bd posiflush xs (code: 306572 - batch: 8337858) used for her home iv's (pre & post infusion).When she twisted off the cap, the area at the tip of the syringe contained the jagged edge, this area is inserted directly into the bung on patients picc line.This was causing plastic particles to fall off.The patients mother has two boxes of flushes at her home and advised the issue was consistent with both boxes - some worse than others.".

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8518777
• MDR Text Key: 151918733
• Report Number: 9616657-2019-00187
• Device Sequence Number: 1
• Product Code: JOL
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8337858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other