MAUDE Adverse Event Report: COPAN FLOCK TECHNOLOGIES S.R.L. / COPAN DIAGNOSTICS, INC. FLOQSWABS; APPLICATOR, ABSORBENT TIPPED, STERILE

Model Number FLOQSWABS, FLEXIBLE

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Discomfort (2330); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 06/23/2020

Event Type  Injury  

Event Description

A (b)(6) year old adult female came to er for routine sars-cov-2 test specimen collection ("drive-through" collection).Swab used was "floqswabs flexible, sterile, wrapped, molded bp 100mm) ref # 220252, batch 098l18, lot 180824252, expiration 5/31/2021.Swab entered right nostril and broke off at junction of slender shaft and thicker shaft handle.Per the collecting nurse, the patient did not struggle or move about during collection.In order to remove the swab end, the patient was taken to the operating room.According to the operative report, an endoscope was utilized.Due to the difficulty of removal and extreme discomfort, patient consented to sedation.It was noted no bleeding or coughing/signs of aspiration were seen.Occurrence was during specimen collection for sars-cov-2 pcr testing to be performed at local county health laboratory (b)(6).Due to need for a procedure to remove the swab, a rapid molecular method (abbott id now) was used.Fda safety report id# (b)(4).

• Brand Name: FLOQSWABS
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): COPAN FLOCK TECHNOLOGIES S.R.L. / COPAN DIAGNOSTICS, INC.
• MDR Report Key: 10205871
• MDR Text Key: 196949952
• Report Number: MW5095248
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 50382902202528
• UDI-Public: (01)50382902202528
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• 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 Model Number: FLOQSWABS, FLEXIBLE
• Device Catalogue Number: 220252
• Device Lot Number: 180824252
• 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?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 62