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 Problems Sedation (2368); Obstruction/Occlusion (2422)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Through the course of the investigation, which included a visual inspection of the retain complaint kit lot, no product problem was identified.The cobas pcr media dual swab kit instructions for use provide adequate instruction on the proper collection of oropharanygeal samples.(b)(4).

Event Description

A (b)(6) customer reported that upon admission of a new patient, the bedside nurse was performing a covid 19 nose and throat swab with the cobas pcr dual media swab kit.The nose swab went as normal but on doing the mouth swab, the end of the swab snapped off inside the patients mouth.No force was used by the nurse on using the swab.A doctor examined the patient's mouth and could see the retained swab with use of oral suction and a pen torch.The patient's sedation had to be deepened while the doctor extracted the swab using forceps; no further details were provided.It was noted that there was no damage visible to mouth.

• 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
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 10509864
• MDR Text Key: 206301547
• Report Number: 2243471-2020-00019
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/09/2020

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 Expiration Date: 01/31/2022
• Device Catalogue Number: 07958021190
• Device Lot Number: G02949
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention