MAUDE Adverse Event Report: EXELINT INTERNATIONAL EXEL HYPODERMIC DISPOSABLE NEEDLE; HYPODERMIC NEEDLE

Model Number	26427
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We began the reporting process as soon as we received the report.We encountered issues with the setup and installation of webtrader software required for electronic submission that prevented us from submitting the report within the allowed timeframe.We spent considerable time trying to resolve the issue with the helpdesk until it was resolved.We have records of communication with esg help-desk to provide for verification of technical difficulties if needed.
Event or Problem Description
A 27 gauge needle was used to circumferentially inject lidocaine around the soft tissue neck mass on (b)(6) 2019.The mass was not fixed to the skin or underlying muscle.The needle was being withdrawn without difficulty from one of the subcutaneous injection sites and spontaneously detached from the hub, beneath the skin.It was not bent or torqued before or during the injection process.The needle was unable to be located during this excisional biopsy procedure.The excisional biopsy was completed however.Soft tissue x-rays on (b)(6) 2019 revealed an intact, unbent needle beneath the skin and surgical incision.It was removed under fluoroscopic guidance on (b)(6) 2019.A separate new incision was used for the removal.A hemostat was used to grasp the needle and it was bent only at the time of extraction.At no time was the needle bent during the original procedure.This is confirmed by x-rays prior to the extraction procedure of (b)(6) 2019.Surgery and localization were difficult and required general anesthesia for the needle extraction procedure.
Additional Manufacturer Narrative
Correction of date of incident to 02/20/2019, correction of lot number to 160227.Complaint #: (b)(4).

• Brand Name: EXEL HYPODERMIC DISPOSABLE NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): EXELINT INTERNATIONAL; 2500 santa fe ave; redondo beach CA 90278
• Manufacturer (Section G): EXELINT INTERNATIONAL CO.; 2500 santa fe ave; redondo beach CA 90278
• Manufacturer Contact: elvia lopez ; 2500 santa fe ave; redondo beach, CA 90278 ; 3106490707
• MDR Report Key: 8600059
• Report Number: 1035907-2019-00001
• Device Sequence Number: 2294346
• Product Code: FMI
• UDI-Device Identifier: 10020221264279
• UDI-Public: 10020221264279
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: 26427
• Device Catalogue Number: 26427
• Device Lot Number: 160227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2016
• 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: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White