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

Catalog Number	07958021190
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the kit did not identify any issue.Although a root cause cannot be confirmed, the allegation most likely occurred due to customer handling during sample collection.The cobas pcr media dual swab kit instructions for use provide adequate instructions for the proper sample collection.
Event or Problem Description
A customer alleged that a patient swallowed a swab from cobas® pcr media dual swab sample kit during sample collection.The clinician was collecting a throat sample for a cobas 6800 ct/ng test and the shaft broke and the patient swallowed the pcr media swab.The clinician confirmed that there was no harm, discomfort, or injury to the patient and the patient did not have any complications or issues.Medical intervention was not confirmed to retrieve the swab from the patient.No damage was observed on the swab on arrival or prior to immediate use as the clinician uses the swab on the patient.No harm or injury indicated.
Additional Manufacturer Narrative
E1 - added initial reporter's last name and updated email address.

• Brand Name: COBAS® PCR MEDIA DUAL SWAB SAMPLE KIT
• Common Device Name: 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: 14806203
• Report Number: 2243471-2022-00582
• Device Sequence Number: 4960916
• Product Code: MKZ
• UDI-Device Identifier: 00875197005738
• UDI-Public: 00875197005738
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K163184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 07958021190
• Device Lot Number: H33837
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male