MAUDE Adverse Event Report: JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD COLLECTION SWAB & VIRUS SAMPLING TUBE; APPLICATOR, ABSORBENT TIPPED, STERILE

Lot Number 20200502

Device Problem Material Separation (1562)

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

Event Date 09/04/2020

Event Type  Injury  

Event Description

Patient was swabbed oral pharyngeal for covid-19 and when pulled out, the tip of swab had broken and was missing.Fda safety report id # (b)(4).

• Brand Name: COLLECTION SWAB & VIRUS SAMPLING TUBE
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD
• MDR Report Key: 10553050
• MDR Text Key: 207720757
• Report Number: MW5096725
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Lot Number: 20200502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 115