MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS PCR MEDIA DUAL SWAB SAMPLE KIT; SPECIMEN COLLECTION KIT

Catalog Number 07958021190

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Sedation (2368); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Through the course of the investigation, which included a review of qc release records and visual inspection of retain materials, no product problem was found.The cobas pcr media dual swab kit instructions for use provide adequate instructions for the proper sample collection.(b)(4).

Event Description

A (b)(6) customer reported that upon taking a covid swab, with the cobas pcr media dual swab kit, the swab broke.A nurse at the site decided to take a throat swab from the patient's tracheostomy site.Upon inserting the swab into the tracheostomy, it broke with the cotton budded end falling further into the tracheostomy site, being lost to sight.The nurse removed the inner tracheostomy tube to attempt to locate the swab but was unable to visualize it.The swab was removed from l main bronchus through bronchoscope under propofol sedation by a respiratory consultant.The sample was taken for covid testing, but no further details on which test it was collected for was provided.The instructions for use for the cobas pcr media dual swab kit do not instruct the user to collect samples from tracheostomy sites.It does, however, provide instruction on the proper collection of oropharanygeal samples.

• Brand Name: COBAS PCR MEDIA DUAL SWAB SAMPLE KIT
• Type of Device: SPECIMEN COLLECTION KIT
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 10634716
• MDR Text Key: 214759591
• Report Number: 2243471-2020-00126
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 07958021190
• Device Lot Number: G04448
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention