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

Catalog Number 07958030190

Device Problem Insufficient Information (3190)

Patient Problem Nasal Obstruction (2466)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

Although requested, no kit lot information was provided.As such, a through investigation could not be performed.Nasopharyngeal samples are not a validated sample type for cobas pcr media uni swab sample kit per the instructions for use.Customer site name was truncated due to character limitations.(b)(6).(b)(4).

Event Description

During sample collection (nasopharyngeal), a cobas pcr uni swab broke and the swab shaft remained inside the patient.Tweezers needed to be used to remove the broken swab shaft from the patient.No harm was reported for the patient.

• Brand Name: COBAS PCR MEDIA UNI 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: 10376230
• MDR Text Key: 206961701
• Report Number: 2243471-2020-00014
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K163184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 07958030190
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention