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

Catalog Number	07958030190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Gastrointestinal Problem (4491)
Date of Event	09/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation did not identify a product problem.An off-label sample collection was performed.Per the operator's manual, oropharyngeal swab collections are intended to be performed by a clinician.It is possible that the patient accidentally broke the swab at the scoreline during collection.
Event or Problem Description
A customer alleged that a swab, which is packaged in the cobas® pcr media uni swab sample kit, broke during sample collection.The patient was allegedly collecting an oropharyngeal swab when the swab broke during self-collection.It is unclear at what point in the collection process the swab broke and if any treatment was administered.No further harm was reported.

• Brand Name: COBAS® PCR MEDIA UNI SWAB SAMPLE KIT
• Common Device Name: SPECIMEN COLLECTION KIT
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 20418158
• Report Number: 2243471-2024-02945
• Device Sequence Number: 20885272
• Product Code: MKZ
• UDI-Device Identifier: 00875197005721
• UDI-Public: 00875197005721
• Combination Product (Y/N): Y
• Initial Reporter Country: SW
• PMA/510(K) Number: K163184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 07958030190
• Device Lot Number: 77698501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown