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

Catalog Number 300296

Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

(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 with the use of the bd discardit ii syringe w/o needle there was an issue with leakage from the back of the body, cannula not sitting firmly on cone, scaling difficult to see and fingertip is broken off on syringe.

Manufacturer Narrative

Investigation: bd has reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Bd has been provided with the affected sample.The leakage test performed on the sample reveal no defect.In addition, no defect in the syringe tip or in the hub of the needle was observed after the evaluation.The scale marking of the returned syringe was correct, and no breakage was observed.After the evaluation of the received sample, bd could not determine the exact root cause of the reported issue.Bd believes the cause of the problem could be 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 has tested the provided sample tip with a gauge and the dimensions were correct in this case.Bd has also carried out a leakage test to check the possible of air loss due to a bad connection and it has proved to be correct too.Based on the nonconformance description, bd believes the issue could be related with some ineffective luer slip fitting between the device and the syringe tip.The exactly root cause for this issue is not possible to be determinate.The process bd uses to print the scale is called "hot stamping system".A metal stamp is heated at around 100ºc.Between the stamp and the barrel, bd interposes a special black printing foil.By pressure, the stamp pushes the printing foil and its component is embedded in the barrel wall.The result is a black scale printed on the barrel of the syringe.Based on the customer feedback, the reported issue could happened at the end of this process, due to a defective foil reel.In this case the foil did not work as expected, and the scale was not printed correctly.The material used to manufacture discardit syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100 % the syringes, rejecting automatically the syringes with broken parts.Based on this fact, bd believes that the syringe tip could break because of any imperceptible damage in the barrel at the moment of the use or some strong condition during handling or use of the product.

Event Description

It was reported with the use of the bd discardit¿ ii syringe w/o needle there was an issue with leakage from the back of the body, cannula not sitting firmly on cone, scaling difficult to see and fingertip is broken off on syringe.

• Brand Name: BD DISCARDIT II SYRINGE W/O NEEDLE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8293973
• MDR Text Key: 134900400
• Report Number: 3002682307-2019-00115
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 300296
• Device Lot Number: 1806173
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other