MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 6MM (15/64"); PISTON SYRINGE

Model Number	328520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 relion insulin syringes 1/2ml 31 gauge, 6mm (15/64") experienced hub separation from the device.The following information was provided by the initial reporter: consumer reported found 1 syringe the tip of syringe broke/snapped off when removed needle shield.
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 2 relion insulin syringes 1/2ml 31 gauge, 6mm (15/64") experienced hub separation from the device.The following information was provided by the intiail reporter: consumer reported found 1 syringe the tip of syringe broke/snapped off when removed needle shield.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 03-jan-2023.H6: investigation summary customer returned (4) 1/2cc, 6mm, 31g relion syringes in open poly bags from lot # 1088077.Customer states that the tip of syringe broke/snapped off when removed needle shield.All returned syringes were tested to determine the shield removal forces (specs: shield removal force for 1/2cc after sterilization: 0.85-5.95 lbs.).Data: shield removal force: syringe 1, 2.29 lbs.Syringe 2, 1.78 lbs.Syringe 3, 3.75 lbs.Syringe 4, 3.11 lbs.All removal forces fall within specification.No hub assembly separated from the barrel when the shield was removed.A review of the device history record was completed for batch# 1088077.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

• Brand Name: RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 6MM (15/64")
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15859398
• Report Number: 1920898-2022-00824
• Device Sequence Number: 5845776
• Product Code: FMI
• UDI-Device Identifier: 00681131138369
• UDI-Public: 00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: Other
• Device Expiration Date: 04/30/2026
• Device Model Number: 328520
• Device Catalogue Number: 328520
• Device Lot Number: 1088077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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