MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC PLS UNTR-20PK 1000; ORAL SWAB

Catalog Number 6071

Device Problem Material Separation (1562)

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

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

Reported discarded the involved device, however, provided a lot number for review.Product history records were reviewed, all quality checks performed indicated passing results and all release criteria were met per the product drawing.A labeling review of the finished good was performed.The instructions for use state "use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use.If not, remove any particles from oral cavity." the review of the label is adequate for the intended use of the device and did not contribute to the reported failure.The root cause of the reported complaint is most likely due to user error of patient biting the swab.Discarded by facility.

Event Description

Report received of a malfunction resulting in an oral swab disengagement.Oral care was performed by a nurse on an alert and oriented patient.The reporter stated the patient bit down causing the green foam to disengage inside the patient¿s mouth.Reporter stated the disengaged foam was successfully retrieved without difficulty by the nurse and no injury occurred.The reported issue occurred during the initial use of device and no bite block was in use.The involved device was discarded; however, lot information was provided.Although requested, no additional information was available.

• Brand Name: TOC PLS UNTR-20PK 1000
• 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: susie hinkle ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 11515974
• MDR Text Key: 242785997
• Report Number: 0001419181-2021-00006
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2021

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: Health Professional
• Device Catalogue Number: 6071
• Device Lot Number: 78230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• 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
• Patient Age: 60 YR