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

Catalog Number 309110

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

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).Initial reported fax #:(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 that the bd discardit¿ ii 10 ml syringe experienced leakage past the plunger.The following information was provided by the initial reporter: in this batch / syringe, drug leaked from the back of the syringe.Defect on the syringe plunger.

Event Description

It was reported that the bd discardit¿ ii 10 ml syringe experienced leakage past the plunger.The following information was provided by the initial reporter: in this batch / syringe, drug leaked from the back of the syringe.Defect on the syringe plunger.

Manufacturer Narrative

Investigation summary a device history record review was completed for provided lot number 2001210.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were not returned, twenty retained samples were obtained for further evaluation.The retained samples were inspected; however, no signs of defect could be identified.Per the provided feedback, it is possible that the issue resulted from an ineffective luer slip fitting between the needle and the syringe tip.This type of issue may result from defective luer dimensions or damage to the product.The exact cause cannot be determined with the limited investigation results.

• Brand Name: BD DISCARDIT¿ II 10 ML SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12619400
• MDR Text Key: 276162437
• Report Number: 3002682307-2021-00548
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309110
• Device Lot Number: 2001210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1