MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 6MM 10BAG 500CS; PISTON SYRINGE

Model Number	324912
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the syringe 1.0ml 31ga 6mm 10bag 500cs experienced a deformed stopper.The following information was provided by the initial reporter: material no: 324912.Batch no: 0258080.Consumer reported that the black rubber stopper is melted inside of the syringe.Date of event: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.H6: investigation summary: customer returned (1) loose 1ml bd insulin syringe.Consumer reported that the black rubber stopper is melted inside of the syringe.The returned sample was examined, and it was observed that the stopper was damaged/disfigured within the barrel.A review of the device history record was completed for batch# 0258080.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to confirm the customer¿s indicated failure of the stopper damaged/disfigured within the barrel.H3 other text : see h10.
Event or Problem Description
It was reported that the syringe 1.0ml 31ga 6mm 10bag 500cs experienced a deformed stopper.The following information was provided by the initial reporter: material no: 324912, batch no: 0258080.Consumer reported that the black rubber stopper is melted inside of the syringe.Date of event: unknown.

• Brand Name: SYRINGE 1.0ML 31GA 6MM 10BAG 500CS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11872183
• Report Number: 1920898-2021-00590
• Device Sequence Number: 10963719
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2025
• Device Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 0258080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1