MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGES 1/2ML 31 GAUGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328520
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using relion insulin syringes 1/2ml 31 gauge there was foreign matter found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported when he pushed down on the plunger rod, "clear clumps of liquid" came from barrel of syringe.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no samples or 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# 2087334.All inspections were performed per the applicable operations qc specification.H3 other text : see h10.
Event or Problem Description
It was reported while using relion insulin syringes 1/2ml 31 gauge there was foreign matter found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported when he pushed down on the plunger rod, "clear clumps of liquid" came from barrel of syringe.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes, d.9.Returned to manufacturer on: 06nov2023.H.6.Investigation summary: samples were received and an investigation was performed.This is the 2nd complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
Event or Problem Description
It was reported while using relion insulin syringes 1/2ml 31 gauge there was foreign matter found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported when he pushed down on the plunger rod, "clear clumps of liquid" came from barrel of syringe.

• Brand Name: RELION INSULIN SYRINGES 1/2ML 31 GAUGE
• 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 ; 8015296192
• MDR Report Key: 15997995
• Report Number: 1920898-2022-00888
• Device Sequence Number: 17590947
• 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: 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,Followup
• Report Date (Section B): 11/09/2023

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 Model Number: 328520
• Device Catalogue Number: 328520
• Device Lot Number: 2087334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 11/09/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/29/2023; 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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