MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL; SYRINGE, PISTON

Model Number	328506
Medical Device Problem Codes	Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported, some of the needles "bend".When taking his injection.Stated, he is concerned, that the needle may break, during injection.Stated, sometimes there is leakage, when taking his injection.And he is not sure, if he's getting all of his insulin.Stated, lately his blood sugar has been anywhere between 170-200, before a meal.Stated, his blood sugar is normally 120 max or under 100 before a meal.Stated, he does re-use syringes sometimes.Stated, he does rotate the different injection sites.Stated, did not seek medical intervention for blood sugar.Lot#: 4082016, catalog: 328506, date of event: unknown.Samples: yes, cl.
Additional Manufacturer Narrative
Additional information was added to: b4, g6, h2, h3, h6 (device problem code) h11.Correction to: h6 (type of investigation and investigation conclusions).Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st 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.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.

• Brand Name: SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
• 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: 20727421
• Report Number: 3024508819-2024-00450
• Device Sequence Number: 8370857
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 01/29/2025

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: 328506
• Device Lot Number: 4082016
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American