MAUDE Adverse Event Report: SAGE PRODUCTS LLC INTL TOC PLS UNTR-INDIV 800; ORAL SWAB

Model Number 6070-X

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2024

Event Type  malfunction  

Event Description

Report received stating pieces of foam from a sage untreated oral swab became separated from the swab into the patient¿s mouth during initial use of the device.Reporter stated that a patient¿s family member inserted the swab into the patient¿s mouth without using a bite block.Reporter stated the patient subsequently bit down on the swab and pieces of foam separated from the swab.A nurse was able to remove the pieces of foam from the patient¿s mouth with their fingers.The patient did not experience any adverse consequences.The device was not available for return.Photos and lot number of the device were not available.Although requested no additional information was available.

Manufacturer Narrative

The involved device was not returned, photographs were not provided, and the lot number was not identified.Therefore, a visual/functional inspection could not be performed.It was alleged by the complainant that during initial use of the sage untreated oral swab from the 6070-x package, a family member was using the device, a bite block was not in use and the patient bit down on the device and bits of the swab had come off of the device.The instructions for use state "do not allow patient to bite down on the oral care tool.Use a bite block if patient has altered levels of consciousness or cannot comprehend commands.Use caution with children and unresponsive individuals.Failure to follow these safety precautions may damage the device and present a choking/aspiration hazard." the reported complaint is not likely to be a quality or a manufacturing defect.The root cause is due to customer misuse as the patient bit down on the product and a bite block was not in use.H3 other text : device not available for return per reporter.

• Brand Name: INTL TOC PLS UNTR-INDIV 800
• Type of Device: ORAL SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer (Section G): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer Contact: maeve linder ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 18903965
• MDR Text Key: 337672291
• Report Number: 0001419181-2024-00001
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6070-X
• Device Catalogue Number: 6070-X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/14/2024
• 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: Initial
• Patient Sequence Number: 1