MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL HYPO NDL 27GX1-1/2"; HYPODERMIC NEEDLE

Catalog Number	26426
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Two needles were bent in half and one broke off in the patient during injection.The needle broke off at the plastic to the metal connection.The patient had to be taken by ambulance to the hospital to have the needle removed.  the hospital personnel in the emergency department had the proper equipment to remove the needle by opening the injection site under a local anesthesia and were able to remove it without requiring more invasive surgery.A lot search revealed one (cmp-37) similar complaint event from this product/lot combination.Investigation is ongoing.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
Correction: component code g should have been included in initial mdr.Additional information: retention sample inspection conducted - 10 pcs each: visual inspection - outer surface of needle tubes inspected with 10x magnifying glass and all samples found to be smooth and without defects rigidity and toughness test - all samples passed rigidity and toughness test of the needle tubes connection firmness test - applied 22n of pulling force on the needle and all samples did not become loose or separate at the needle hub and needle tube batch records were reviewed and no issues were noted in adhesive, rigidity and toughness, production process, or raw materials the root cause cannot be confirmed as no images or samples were provided for evaluation.A potential cause of the needle breakage is improper use.Per iso 9626:2016, the needle must be able to pass 20 bending tests at 20 ± 1 degrees for thin wall needles without breaking.Needles bent past its deflection properties may break.(b)(4).

• Brand Name: EXEL HYPO NDL 27GX1-1/2"
• 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: 19224303
• Report Number: 1035907-2024-00019
• Device Sequence Number: 12488560
• Product Code: FMF
• UDI-Device Identifier: 00020221264265
• UDI-Public: (01)00020221264265
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 26426
• Device Lot Number: 230602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/03/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown