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 Problem Foreign Body In Patient (2687)

Event Date 05/26/2022

Event Type  malfunction  

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 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.

Manufacturer Narrative

E1 - added initial reporter's last name and updated email address.

• 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: 14806203
• MDR Text Key: 303314490
• Report Number: 2243471-2022-00582
• Device Sequence Number: 1
• Product Code: MKZ
• UDI-Device Identifier: 00875197005738
• UDI-Public: 00875197005738
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 07958021190
• Device Lot Number: H33837
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 06/27/2022
• 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?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male