MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT II 10 ML SYRINGE; PISTON SYRINGE

Catalog Number 309110

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, a supplemental report will be filed.

Event Description

It was reported that during use there is a poor seal and leakage occurs with a bd discardit¿ ii 10 ml syringe.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 trepan biopsy.

Manufacturer Narrative

H.6.Investigation summary: bd has been provided with samples for catalog 309110 lot 1909171 to investigate for this record.Visual examination of the samples through magnification shows a leakage through the plunger rod.As a result, bd was able to verify the reported issue.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.The device history review showed no indication of the alleged defect.Considering our in-coming and in-process inspection, no corrective actions are required at this time.H3 other text : see section h.10.

Event Description

It was reported that that during use there is a poor seal and leakage occurs with a bd discardit¿ ii 10 ml syringe.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 trepan biopsy.

• Brand Name: BD DISCARDIT II 10 ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 9526617
• MDR Text Key: 190671946
• Report Number: 3002682307-2019-00691
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309110
• Device Lot Number: 1909171
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other