MAUDE Adverse Event Report: HUNAN RUNMEI GENE TECHNOLOGY CO., LTD RUN ME COVID-19 COLLECTION KIT; APPLICATOR, ABSORBENT TIPPED, STERILE

Lot Number 202005

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  Injury  

Event Description

Malfunction of a viral nasopharyngeal test swab used for covid-19 rt-pcr test.The tip of the nylon swab had lodged in his left nostril.Nurse had noticed the missing tip and asked patient to blow his nose.Patient coughed out the tip and was not in discomfort.No bleeding was noticed.After 8-10 days patient had out his finger in left nose and felt something and called the provider.He was immediately asked to go and see a provider.Patient was seen at urgent care.Provider at urgent care had removed a very small piece (l-shaped) of plastic with retractor from patient's left nose.Patient had no symptoms, no infection, and no bleeding at the time - but the plastic piece was retained for approximately 10 days.Patient is doing fine.Fda safety report id# (b)(4).

• Brand Name: RUN ME COVID-19 COLLECTION KIT
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): HUNAN RUNMEI GENE TECHNOLOGY CO., LTD; changsha, hunan ; CH
• MDR Report Key: 10464860
• MDR Text Key: 204900507
• Report Number: MW5096308
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Lot Number: 202005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR