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	Device Contamination with Chemical or Other Material (2944)
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 while using relion insulin syringes 1/2ml 31 gauge, there was foreign matter found.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported found 1 syringe with a foreign matter inside syringe barrel - hard plastic or rock salt looking piece lot #1088077c catalog# 328520 date of event unknown.Sample status awaiting sample.Consumer reported with 1 syringe a foreign matter inside barrel lot # 1088077a catalog# 328520 date of event unknown.Sample status awaiting sample.
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
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 a foreign matter inside syringe barrel.All returned syringes were examined and no foreign matter was observed in or on any of the returned syringes.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.
Event or Problem Description
It was reported while using relion insulin syringes 1/2ml 31 gauge, there was foreign matter found.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported found 1 syringe with a foreign matter inside syringe barrel - hard plastic or rock salt looking piece lot #1088077c catalog# 328520 date of event unknown sample status awaiting sample consumer reported with 1 syringe a foreign matter inside barrel lot # 1088077a catalog# 328520 date of event unknown sample status awaiting sample.

• 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: 15859260
• Report Number: 1920898-2022-00823
• Device Sequence Number: 12257583
• 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
• 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