MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION® INSULIN SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 before use of the relion® insulin syringe the needle fell out of one syringe when it was touched with a finger.The following information was provided by the initial reporter: "consumer reported, when he removed needle shield prior to injection, the needle was bent.Stated, out of the three that he found bent, the needle fell out of one syringe when he touched it with his finger.3 syringes affected.Lot: 2283727.Catalog: 328520.Date of event: (b)(6) 2023.Samples: yes cl.
Event or Problem Description
It was reported that the before use of the relion® insulin syringe the needle fell out of one syringe when it was touched with a finger.The following information was provided by the initial reporter: "consumer reported, when he removed needle shield prior to injection, the needle was bent.Stated, out of the three that he found bent, the needle fell out of one syringe when he touched it with his finger.3 syringes affected.Lot: 2283727.Catalog: 328520.Date of event: 2023-05-05.Samples: yes cl.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-jun-2023.H6: investigation summary: the customer returned (1) 0.5ml 31g 6mm syringe, reporting breaks off during use.The syringe was visually inspected and observed broken cannula.Based on the sample returned, embecta was able to confirm the customer-indicated failure as broken cannula.A review of the device history record was completed for batch# 2283727.All inspections and challenges were performed per the applicable operations qc specifications.Based on the samples received, embecta was able to duplicate or confirm the customer-indicated failure.No root cause determined at this time.H3 other text : see h10.

• Brand Name: RELION® INSULIN SYRINGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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 ; 8448235433
• MDR Report Key: 17015099
• Report Number: 1920898-2023-00317
• Device Sequence Number: 15345010
• Product Code: FMI
• UDI-Device Identifier: 00681131138369
• UDI-Public: (01)00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• 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): 08/24/2023

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 Model Number: 328520
• Device Catalogue Number: 328520
• Device Lot Number: 2283727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 09/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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