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 Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of the kit did not identify any issue.The customer indicated the swab was intact when the customer received the product.The cobas® pcr media uni swab kit instructions for use (ifu) refers to the assay specific instructions on swab collections.According to the cobas® ct/ng ifu, the anorectal swab specimens should be collected by clinicians.In this case, the patients were instructed by the clinicians and performed self-collection, which was not indicated in the product's ifu and most likely the reason for the swabs breaking.(b)(4).
Event or Problem Description
A customer alleged two incidents when the woven swab, which is packaged in the cobas® pcr media uni swab sample kit, broke off prematurely during a rectal self-collection, for ct/ng testing, instructed by the clinician.One of the patients was able to remove the broken swab by themselves.The second patient had the swab removed in the emergency room.It is unknown if the patient had to stay in the hospital.It is also unknown if the patient was injured during the incident.The patient refused any further contact with the clinic.The customer indicated the swab was intact when the customer received the product.The cobas® pcr media uni swab kit instructions for use (ifu) refers to the assay specific instructions on swab collections.According to the cobas® ct/ng ifu, the anorectal swab specimens should be collected by clinicians.In this case, the patients were instructed by the clinicians and performed self-collection, which was not indicated in the product's ifu and most likely the reason for the swabs breaking.

• 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; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 12814768
• Report Number: 2243471-2021-03699
• Device Sequence Number: 4488649
• Product Code: MKZ
• UDI-Device Identifier: 00875197005721
• UDI-Public: 00875197005721
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K163184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 07958030190
• Device Lot Number: H03250
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/15/2021
• 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): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female