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

Catalog Number 6070-X

Device Problem Material Separation (1562)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing, awaiting returned samples for investigation.

Event Description

Report received of a green toothette swab disengagement.The reporter stated that a patient with mild dementia underwent a videofluoroscopy in which a piece of green foam from the oral swab was coughed up after the procedure was completed.Prior to the procedure the patient had the toothettes provided at the bedside to use unsupervised.Due to the unsupervised nature of the oral care performed by patient it is not possible to determine the date of the disengagement or if this was the initial use of device.Reporter stated patients are usually advised to use the toothette once and then discard.Reporter stated that there were no adverse consequences and no treatment was needed.Reporter stated the nursing staff opened the remaining swabs from the patient¿s room and tested them; each swab head reportedly came away from the middle with little force.The involved device was not returned, however a photograph of the piece of green foam and lot number were provided.Device samples from the same lot as the involved device will be returned for evaluation.Although requested, no additional information was available.

Manufacturer Narrative

Lot number and photograph were provided for review.Facility is in the process of returning samples from the same lot number.A review of the photograph revealed a small piece of the green foam on a white plastic spoon.It was reported that this was the piece of foam the patient coughed up after the videofluoroscopy.Facility returned 111 orals swabs from the same lot number as the oral swab involved in the reported event.Upon visual inspection of the returned swabs, each applicator swab had the foam head completely attached to the straw.Each of the 111 returned oral swabs were pulled with a lot of force, each swab head was securely attached with glue present.Product history records were reviewed, all quality checks performed indicated passing results and all release criteria were met per product drawing.A labeling review of the finished good was performed.The instructions for use state "do not allow patients to bite down on the oral care tool.Use a bite block if patient has altered levels of consciousness or those who 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.May not function as intended/potential risk of cross-contamination if device is reused." additional review was done to analyze the manufacturing process.Analysis revealed a swab head pull test is performed on each of the swabs after it exits the dryer towers.Any of the swabs that fail the swab head pull tester would be rejected.The root cause of the reported complaint cannot be determined.The returned product met specifications as each foam head was securely attached the straw.All of the production records indicated passing results.It was stated that the patient had mild dementia and was left unsupervised, so it is unknown if the patient bit the swab or if the swab was used more than one time, therefore the complaint cannot be a confirmed user error.The reported complaint cannot be determined to be a quality or manufacturing defect.

Event Description

Report received of a green toothette swab disengagement.The reporter stated that a patient with mild dementia underwent a videofluoroscopy in which a piece of green foam from the oral swab was coughed up after the procedure was completed.Prior to the procedure the patient had the toothettes provided at the bedside to use unsupervised.Due to the unsupervised nature of the oral care performed by patient it is not possible to determine the date of the disengagement or if this was the initial use of device.Reporter stated patients are usually advised to use the toothette once and then discard.Reporter stated that there were no adverse consequences and no treatment was needed.Reporter stated the nursing staff opened the remaining swabs from the patient¿s room and tested them; each swab head reportedly came away from the middle with little force.The involved device was not returned, however a photograph of the piece of green foam and lot number were provided.Device samples from the same lot as the involved device will be returned for evaluation.Although requested, no additional information was available.

• 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
• MDR Report Key: 11979827
• MDR Text Key: 265010780
• Report Number: 0001419181-2021-00009
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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: Lay User/Patient
• Device Catalogue Number: 6070-X
• Device Lot Number: 74377
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1