MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT II 20 ML SYRINGE; PISTON SYRINGE

Catalog Number 300296

Device Problem Leak/Splash (1354)

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

Event Date 12/09/2019

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 and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd discardit¿ ii 20 ml syringe there was an issue with leakage.No proper vacuum for taking samples during trepanobiopsy.The following information was provided by the initial reporter: they claim that our syringes do not seal properly.They are using these syringes on the hematology for taking blood samples and samples of bone marrow.There is leakage of blood.No proper vacuum for taking samples during trepanobiopsy.

Event Description

It was reported that during use of the bd discardit¿ ii 20 ml syringe there was an issue with leakage.No proper vacuum for taking samples during trepanobiopsy the following information was provided by the initial reporter: they claim that our syringes do not seal properly.They are using these syringes on the hematology for taking blood samples and samples of bone marrow.There is leakage of blood.No proper vacuum for taking samples during trepanobiopsy.

Manufacturer Narrative

H.6 investigation summary :bd has been provided with samples for catalog 300296 lot 1908143 to investigate for this record.Visual examination using magnification shows a leakage through the plunger rod.As a result, bd was able to verify the reported issue.Bd concludes that the cause the cause of the problem could be produced because of a damage in the plunger tip.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.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 20 ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 9520622
• MDR Text Key: 192176935
• Report Number: 3002682307-2019-00685
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300296
• Device Lot Number: 1908143
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other