MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS; Syringe, Piston

Model Number	328431
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.______________________________________________ this complaint record was reopened/opened and reviewed as part of capas #pr-00078 and #pr-00080.The review revealed that this complaint was determined to be a reportable event.The required activities for reporting this event were completed.The review confirmed that the complaint record is consistent with applicable procedures cp62096, cp92021, and regulatory requirements, and separate complaints were opened for each separate event.There was appropriate follow-up (if this was required), and each event is addressed based on the most current information.There are no additional events or updates that meet the fda mdr reporting requirements.No further action is required at this time unless new information becomes available.Anand yadav ¿ 17sep2026.
Event or Problem Description
Consumer reported that there is a black streak on the barrel of 2 syringes.The syringes and packaging have been discarded.Consumer was not able to provide the lot #.Lot #: unknown catalog #: 328431 date of event: unknown samples: discarded.

• Brand Name: SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS
• Common Device Name: Syringe, Piston
• Manufacturer (Section D): EMBECTA MEDICAL I LLC - HOLDREGE, NE
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 50900090
• Report Number: 3024508819-2026-00163
• Device Sequence Number: 5903744
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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: 328431
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• 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: 10/17/2024
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White