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

Model Number	328418
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated, she had 3 needles break off into her injections site on different days.Stated, she was able to remove the needles all three times.Stated, she was left with some bruising, swelling and soreness as a result of the needle breaks stated, she did not seek medical intervention one break occurred on (b)(6), a second needle break occurred on (b)(6) and the third needle break is "unknown" stated, she stuck her finger on a loose needle in a package of syringes on (b)(6).Stated, issues occurred from the same box and the same package.Stated, she will email a photo to show the bruising on her injection site lot: 4144037, catalog: 328418, date of event: november 10th-needle break, october 16th, needle break, november 9th, needle stick, samples: yes, cl.
Additional Manufacturer Narrative
Additional information was added to: b4, g6, h2, h3, h11.Correction to: h6 (component code, 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 3rd.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 UFII 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: 20855480
• Report Number: 3024508819-2024-00471
• Device Sequence Number: 8688286
• Product Code: FMF
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2026

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: 328418
• Device Lot Number: 4144037
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/10/2025; 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White