MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU RELION PEN NEEDLES 6MM X 31 GAUGE (15/64" X 0.25MM) PEN NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	681131386807
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Deliver (2338)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/22/2023
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 during use with relion pen needles 6mm x 31 gauge (15/64" x 0.25mm) pen needles the insulin leaked and the full does was not delivered.Patients glucose was elevated.The following information was provided by the initial reporter: consumer reported that insulin leaks from the needles after injection.Consumer also reported that his glucose level is elevated and he is not seeing the numbers that he expects after injection.I advised consumer to consult with his doctor regarding the elevated glucose level.
Additional Manufacturer Narrative
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 manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.
Event or Problem Description
It was reported that during use with relion pen needles 6mm x 31 gauge (15/64" x 0.25mm) pen needles the insulin leaked and the full does was not delivered.Patients glucose was elevated.The following information was provided by the initial reporter: consumer reported that insulin leaks from the needles after injection.Consumer also reported that his glucose level is elevated and he is not seeing the numbers that he expects after injection.I advised consumer to consult with his doctor regarding the elevated glucose level.

• Brand Name: RELION PEN NEEDLES 6MM X 31 GAUGE (15/64" X 0.25MM) PEN NEEDLES
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17121330
• Report Number: 3014704491-2023-00252
• Device Sequence Number: 20476591
• Product Code: FMI
• UDI-Device Identifier: 00681131386807
• UDI-Public: (01)00681131386807
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• 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): 06/29/2023

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 Expiration Date: 07/31/2026
• Device Model Number: 681131386807
• Device Catalogue Number: 320617
• Device Lot Number: 1186393
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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