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

Catalog Number 07958021190

Device Problem Insufficient Information (3190)

Patient Problem Nasal Obstruction (2466)

Event Date 07/26/2020

Event Type  Injury  

Manufacturer Narrative

Kit lot information has not yet been provided.If the lot becomes available, an investigation will take place and a supplemental report will be provided.(b)(4).

Event Description

A customer in (b)(6) reported that upon admission of a new patient to critical care unit , a nasal swab was being collected with the pcr dual media swab kit for covid testing when the swab shaft broke and remained inside the patient's nose.The swab shaft could not be visualized.The patient was referred to an ent physician and the swab tip was retrieved by a procedure requiring two scopes.No further details were provided.

Manufacturer Narrative

The kit lot used at the time of the nasal collection could not be confirmed.(b)(4).

• 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
• MDR Report Key: 10511018
• MDR Text Key: 206311286
• Report Number: 2243471-2020-00020
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): N
• PMA/PMN Number: K163184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 07958021190
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention