MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG; PISTON SYRINGE

Model Number 324910

Device Problem Leak/Splash (1354)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe 0.3ml 31ga 6mm halfunit 10bag had the shield not detach as intended and had the hub separate.The following information was provided by the initial reporter: "it was reported that consumer is having problems removing needle shield from syringe and when it is removed the needle hub separates from syringe into shield.Consumer attempted to remove hub and needle from shield which caused the needles to bend and caused a needle stick.".

Manufacturer Narrative

H.6.Investigation summary: no samples (including photos) were returned as of 7 may 2020 therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch # 9210500 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200840071] noted for out of spec shield pull.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that syringe 0.3ml 31ga 6mm halfunit 10bag had the shield not detach as intended and had the hub separate.The following information was provided by the initial reporter: "it was reported that consumer is having problems removing needle shield from syringe and when it is removed the needle hub separates from syringe into shield.Consumer attempted to remove hub and needle from shield which caused the needles to bend and caused a needle stick.".

• Brand Name: SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9997907
• MDR Text Key: 189470538
• Report Number: 1920898-2020-00419
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249107
• UDI-Public: 00382903249107
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 324910
• Device Catalogue Number: 324910
• Device Lot Number: 9210500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other