MAUDE Adverse Event Report: SHANDONG YAOHUA MEDICAL INSTRUMENT CORPORATION NASAL SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE

Lot Number 20210427

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2021

Event Type  Injury  

Event Description

[nasal swab] use for covid-19 under emergency use authorization (eua): swab manufactured by shandong yaohua medical instrument corporation on 4/27/2021 broke off at shear point during collection and was stuck inside patient sinus cavity.Upon inspection of swabs in sealed packaging, several swabs were found to have broken prematurely.Fda safety report id# (b)(4).

• Brand Name: NASAL SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): SHANDONG YAOHUA MEDICAL INSTRUMENT CORPORATION; no. 5 zhujiang street, 271100; laiwu, shandong province ; CH
• MDR Report Key: 12487564
• MDR Text Key: 272147233
• Report Number: MW5104040
• Device Sequence Number: 1
• Product Code: KXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Lot Number: 20210427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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): Hospitalization
• Patient Age: 69 YR