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
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 anorectal sample and the swab broke during self-collection.Part of the swab was lodged in the patient¿s rectum.The patient reportedly went to the emergency room to have the swab fragment removed.It could not be confirmed what treatment the patient received or if they were admitted.No further harm was reported.
Additional Manufacturer Narrative
The investigation did not identify a product problem.An off-label sample collection was performed.Per the operator's manual, anorectal swab collections are intended to be performed by a clinician.It is possible that the patient accidentally broke the swab at the shoreline during collection, resulting in the swab getting lodged in the rectum during self-collection.

• 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: 20418143
• Report Number: 2243471-2024-02944
• Device Sequence Number: 18207262
• 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