MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.5ML 31G 6MM S/C U-100 RELION; SYRINGE, PISTON

Model Number	328520
Medical Device Problem Codes	Leak/Splash (1354); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported found 1 syringe when removed the needle shield, the needle hub stayed in the shield.Occd (b)(6) 2023 dc.Consumer reported found 1 syringe needle shield would not remove from syringe (b)(6) 2023 dc.Lot # 3065237.Catalog# 328520.Sample status: awating sample.Consumer reported found 1 syringe hard to press the plunger when drawing air into syringe dc.Consumer reported found 2 syringes from this box with excess lube inside syringe when drawing up the insulin dc.Lot # 1343554.Catalog# 328520.Date of event: 11/15/2023.Sample status awating sample.Cs0069519/sf00018218.
Additional Manufacturer Narrative
Device investigation is in progress.Investigation summary will be submitted once is completed.
Additional Manufacturer Narrative
Correction to h6 (investigation findings, investigation conclusions).Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and one 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.

• Brand Name: SYRINGE 0.5ML 31G 6MM S/C U-100 RELION
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
• Manufacturer (Section G): BECTON DICKINSON AND CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18586935
• Report Number: 1920898-2024-05018
• Device Sequence Number: 7076706
• Product Code: FMF
• UDI-Device Identifier: 00681131138369
• UDI-Public: 00681131138369
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2024

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 Lot Number: 3065237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 04/23/2024; 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown