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

Catalog Number 309050

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/24/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (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 during use of the bd discardit¿ ii syringe ¿during drug or blood aspiration there is significant leakage to the space between barrel and plunger, no precise syringe calibration.Health care worker was exposed to blood however personal protective equipment worn, no direct contact with skin.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: sample evaluation n/a.Bhr review we have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qa nor ncmr's.Syringes were packed in machine nº2024 (september 17 - 19th, 2017).Syringes were assembled in machine, nº4255, nº4254, nº4237, nº4236, and nº4220, in lot #7251002 (september 11 - 18th, 2017) and in lot #7258082 (september 18 - 25th, 2017).Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrels lots #7258040, #7251464, #7244048, and #7237223 and no problems, defects or qn related to the reported issue were found.We have also reviewed the plunger lots #7258041, #7251467, and #7244049 and no problems, defects or qn related to the reported issue were found.Investigation conclusion: root cause analysis we conclude that the cause of the problem could be produced as a consequence 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.Confirmation no samples available for evaluation.No issue found in the bhr.We could not confirm the reported issue.Capa determination no - based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.

• Brand Name: BD DISCARDIT¿ II SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7323592
• MDR Text Key: 101994997
• Report Number: 3002682307-2018-00061
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 309050
• Device Lot Number: 1709187
• Date Manufacturer Received: 02/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other