MAUDE Adverse Event Report: SAGE PRODUCTS LLC INTL TOC SGL USE W/PROX MM 100; ORAL SWAB

Model Number 6013-X

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter discarded the involved product, however, provided a photograph and lot information for review.Evaluation of photograph revealed one opened package with two (2) green foam pieces disengaged from the oral swab head.Green foam was still attached to the swab stick indicating the presence of glue.The reporter confirmed the patient bit down on the foam causing the green foam to disengage from the swab stick.Production history records for the reported lot were reviewed.All in-process quality checks indicated passing results.A labeling review of the finished good was performed.The instructions for use state, "do not allow patient to bite down on 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 review of the label is adequate for the intended use of the device and did not contribute to the reported failure.The root cause could be attributed to user error related to biting and not using a bite block during use of the product.Due to the review of the photograph, review of labeling, and review of the product history and manufacturing records, there is insufficient evidence to conclude the reported issue was attributable to a quality defect or manufacturing operations.

Event Description

Report received of a malfunction resulting in a oral swab disengagement.Oral care was performed by a nurse on a patient who suffers from dementia and was unable to follow commands.The reporter stated the patient bit down on the oral swab and green foam pieces disengaged inside the patient's mouth.Reporter stated the disengaged foam was successfully retrieved and no injury occurred.The reported issue occurred during initial use of the device and no bite block was in use.The device was discarded, however, photographs and lot information were provided.Although requested, no additional information was available.

• Brand Name: INTL TOC SGL USE W/PROX MM 100
• 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: heather sirianni ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 9007941
• MDR Text Key: 219394295
• Report Number: 0001419181-2019-00009
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 09/12/2019

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 Expiration Date: 09/10/2020
• Device Model Number: 6013-X
• Device Catalogue Number: 6013-X
• Device Lot Number: 67456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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