MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULINE SYRINGE; PISTON SYRINGE

Catalog Number	328520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 shield for the relion insuline syringe was crushed.The following was received from the initial reporter: consumer reported finding one syringe in bag with a crushed needle shield stated, it was inside a new box prior to use.
Additional Manufacturer Narrative
H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 3065240.All inspection performed per the applicable operations qc specification.
Event or Problem Description
It was reported that the shield for the relion insuline syringe was crushed.The following was received from the initial reporter: consumer reported finding one syringe in bag with a crushed needle shield stated, it was inside a new box prior to use.

• Brand Name: RELION INSULINE SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17686777
• Report Number: 1920898-2023-00597
• Device Sequence Number: 14960497
• Product Code: FMI
• UDI-Device Identifier: 00681131138369
• UDI-Public: (01)00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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 Catalogue Number: 328520
• Device Lot Number: 3065240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown