MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL HYPO NDL 18GX1"; HYPODERMIC NEEDLE

Catalog Number	26419
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, black rubber particle was found floating in syringe of propofol after withdrawing from vial using 18g needle.The provider observed the particle in the syringe after drawing up the propofol.  she happened to see it floating against the wall of the syringe, then adhering to it.  unfortunately, the product was disposed and cannot be returned for further evaluation.There are no similar complaint type events from this lot.Per investigation, 10pcs of retained samples passed testing for needle intracavity cleanliness.As no images or samples were retained the following are possible causes: puncture debris from the propofol vial when using the disposable needle, foreign matter in the syringe rubber gasket.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: EXEL HYPO NDL 18GX1"
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach CA 90278
• Manufacturer Contact: vu doan ; 2500 santa fe avenue; redondo beach, CA 90278 ; 3106490707
• MDR Report Key: 19226909
• Report Number: 1035907-2024-00020
• Device Sequence Number: 6015899
• Product Code: FMF
• UDI-Device Identifier: 00020221264197
• UDI-Public: (01)00020221264197
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K861153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: Health Professional
• Device Expiration Date: 08/12/2026
• Device Catalogue Number: 26419
• Device Lot Number: 210912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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