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

Catalog Number 07958030190

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2020

Event Type  Injury  

Manufacturer Narrative

Through the reported case, it was noted that the cobas pcr media uni swab was not broken prior to use and it was likely broken at the score-line by the patient during sample collection due to their gag reflex.Instructions exist in the cobas pcr media uni swab kit instructions for use regarding proper sample collection.Facility name was truncated due to character limitations.The name of the facility is: (b)(4).(b)(4).

Event Description

A customer in (b)(6) reported a patient swallowed the shaft of the cobas pcr media uni swab during collection of a specimen from the bilateral posterior pharynx.As a consequence, the patient was brought into the intensive care unit and underwent two procedures (bronchoscopy and endoscopy) to locate the swallowed swab shaft.The swab shaft was located in the patient's upper third of the esophagus, and was successfully removed.The patient is now reported as doing well.

• 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: 10097320
• MDR Text Key: 194117038
• Report Number: 2243471-2020-00010
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 07958030190
• Device Lot Number: F26931
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2020
• 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?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1