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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HARDY DIAGNOSTICS VIRUS TRANSPORT MEDIUM WITH SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE
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HARDY DIAGNOSTICS VIRUS TRANSPORT MEDIUM WITH SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE Back to Search Results
Lot Number 20200515
Device Problem Material Fragmentation (1261)
Patient Problems Viral Infection (2248); Foreign Body In Patient (2687)
Event Date 08/11/2020
Event Type  malfunction  
Event Description
Rn attempted to obtain covid-19 polymerase chain reaction (pcr) per order.Swab inserted through left nare.After removing from nare, swab not intact.Tip of the swab was not able to be seen in the patient's nare.Certified case manager (ccm) contacted.Plans to consult ent.Specimen able to be obtained from right nare with a new swab.Central item # (b)(4) "virus transport medium with swab for the collection and transportation of virus specimens" lot #: 20200515.Mfg #: 20200515.Per consultation note: "ent consulted for covid swab broken off in nose.Patient intubated in the icu with positive covid.Chart reviewed.Patient non-responsive during examination and retrieval of swab.Endoscope used to view the left nasal cavity.Alligator forceps used to remove the swab.Ng (nasogastric) tube secured in right nasal cavity.No other lesions noted of nasal cavities.".
 
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Brand Name
VIRUS TRANSPORT MEDIUM WITH SWAB
Type of Device
APPLICATOR, ABSORBENT TIPPED, STERILE
Manufacturer (Section D)
HARDY DIAGNOSTICS
1430 west mccoy lane
santa maria CA 93455
MDR Report Key12083844
MDR Text Key258888531
Report Number12083844
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number20200515
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2021
Event Location Hospital
Date Report to Manufacturer06/29/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age20440 DA
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