MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 2ML

Catalog Number 300928

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.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified number of syringes s2 2ml experienced leakage/product damage/deformation -device still operable.Product defect was noted during use.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.Our syringes are bad quality and the haematooncology ward does not use them any more.No proper vacuum for taking samples during trepanobiopsy.

Event Description

It was reported that an unspecified number of syringes s2 2ml experienced leakage/product damage/deformation -device still operable.Product defect was noted during use.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.Our syringes are bad quality and the haematooncology ward does not use them any more.No proper vacuum for taking samples during trepanobiopsy.

Manufacturer Narrative

H.6.Investigation summary: bd has been provided with samples for catalog 300928 lot 1902131 to investigate for this record.Visual examination of the sample through magnification shows a leakage through the plunger rod was observed.Bd concludes that the cause of the problem was 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 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 section h.10.

• Brand Name: SYRINGE S2 2ML
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 9526896
• MDR Text Key: 190672329
• Report Number: 3002682307-2019-00692
• 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: 300928
• Device Lot Number: UNKNOWN
• 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: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other