MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL 10-12ML SYR 20GX1" L-L; SYRINGE WITH NEEDLE

Model Number 26254

Device Problem Contamination (1120)

Patient Problem Phlebitis (2004)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

We have checked the retained samples as soon as below complaint was received, and no abnormal was found.This can be found in cmp (b)(4).

Event Description

The following is a legacy complaint that was investigated and closed in 2020 but is being re-opened in qualio because the incident should have originally been a reportable event.Reference capa-34 for explanation.While using this brand of needle syringe combo- multiple patients experiencing phelbitis- inflammation of injection spot.Then noticed while drawing different injections, black particles from the rubber stopper in syringe floating in solution.

• Brand Name: EXEL 10-12ML SYR 20GX1" L-L
• Type of Device: SYRINGE WITH 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: 19023036
• MDR Text Key: 339154260
• Report Number: 1035907-2024-00008
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20221262544
• UDI-Public: 20221262544
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: 26254
• Device Lot Number: 181114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other