MAUDE Adverse Event Report: HEALGEN SCIENTIFIC CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST; COVID RAPID ANTIGEN SELF-TEST

Catalog Number 10973870

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2023

Event Type  malfunction  

Manufacturer Narrative

Customer stated that they noticed a small piece of plastic blocking each of the extraction tube tips, which they believe ultimately caused the top to pop off when applying pressure.The manufacturer is investigating the customer's allegation.There is no allegation of harm and no indication that any medical intervention was required.The customer submitted this event under mw5149385.The cause of this event is unknown.

Event Description

Customer reported difficulty squeezing and dispensing the sample from all the tubes due to defective tips.The liquid won't pass through the filter.The top popped off due to squeezing hard and caused buffer solution and sample to spray.There is no report of injury due to this event.

Manufacturer Narrative

The manufacturer has completed the investigation.Retained samples of the lot in use at the time of the event were inspected and no irregularities were observed.The supplier of the extraction tube also reported no irregularities associated with related batches.Tt is important that the tube is squeezed as instructed in the instructions for use (ifu).The user should gently squeeze the bottom of the tube so that the liquid will drip slowly.Squeezing near the cap of the tube could result in the cap "popping" off.No product problem identified.

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST
• Type of Device: COVID RAPID ANTIGEN SELF-TEST
• Manufacturer (Section D): HEALGEN SCIENTIFIC; 3818 fuqua st.; houston TX 77047
• Manufacturer (Section G): ZHEJIANG ORIENT GENE BIOTECH CO. LTD.; #3784 east yangguang avenue; dipu street anji; huzhou, zhejiang 31330 0; CH 313300
• Manufacturer Contact: cindy horton ; 3818 fuqua st.; houston, TX 77047
• MDR Report Key: 18463513
• MDR Text Key: 332985916
• Report Number: 3009238284-2024-00015
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 10973870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1