MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT II SYRINGE WITH NEEDLE

Catalog Number 300294

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954); Material Protrusion/Extrusion (2979)

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

Event Date 12/14/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd discardit ii¿ syringe with needle has been found experiencing 10 occurrences of blood backflow during use.The following has been provided by the initial reporter: discardit syringe was used in dialysis dept.On infusion pump.Had blood backflow in syringe causing blood spillage.

Event Description

It has been reported that the bd discardit ii¿ syringe with needle has been found experiencing 10 occurrences of blood backflow during use.The following has been provided by the initial reporter: discardit syringe was used in dialysis dept.On infusion pump.Had blood backflow in syringe causing blood spillage.

Manufacturer Narrative

H.6 investigation summary: bd has been provided with a photo for catalog 300294 lot 1902518 to investigate for this record.Visual examination of the photo shows a leakage through the plunger rod.As a result, bd was able to verify the reported issue.The cause of the problem may have been produced because of a damage in the plunger lip.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.Bd recommends the use of 3 pcs bd syringes with luer lock tip to administer medication via a syringe pump.The bd 3 pcs syringe has a natural rubber stopper which provides a smoother performance in terms of plunger advancement at low speed.A luer lock fitting ensures a safer connection with the infusion line compared to a luer slip tip, thus reducing the risk of disconnection of the infusion line.In addition, it is preferable that the syringe pump is placed at the same height of the patient, horizontally.This is to avoid the difference in pressure between atmosphere and vein as it could lead the syringe to empty by its own.The device history review showed no indication of the alleged defect.Considering our in-coming and in-process inspection and since this is the first time this lot is reported for this defect, no corrective actions are required at this time.H3 other text : see h.10.

• Brand Name: BD DISCARDIT II SYRINGE WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 9540539
• MDR Text Key: 192178748
• Report Number: 3002682307-2019-00700
• Device Sequence Number: 1
• Product Code: FMF
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 300294
• Device Lot Number: 1902518
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other