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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC PLS BCRB-20PK 1000; SINGLE USE ORAL SWAB
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SAGE PRODUCTS LLC TOC PLS BCRB-20PK 1000; SINGLE USE ORAL SWAB Back to Search Results
Model Number 6076
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Event Description
It was reported that a piece of the foam from a sage single use oral swab became disengaged inside a patient's mouth during initial use of the device.The nurse did not know the cause of the foam disengagement.However, she stated the patient did not bite the swab.The patient was sedated, not alert or oriented and had an endotracheal tube in place.The nurse was able to remove the disengaged piece of foam from the patient¿s mouth with her fingers after the endotracheal tube was moved to the other side.There was no adverse consequence or clinically relevant delay in treatment related to this event.Although requested, no further information was available.Awaiting product return.
 
Manufacturer Narrative
Awaiting samples to be returned.Investigation ongoing.
 
Manufacturer Narrative
The device used during this event was discarded, however; a photo of the device used was provided and reviewed.It showed the affected swab with approximately ¼ of the top of the foam missing.14 samples from the same lot as the affected device were returned.The returned samples were then each evaluated and it was determined that all 14 of the swabs had the presence of glue and were completely attached to the straw.Product history records were reviewed: all quality checks performed indicated passing results and all release criteria were met per the product drawing.The root cause of the reported complaint could not be determined.It is unknown how or why the foam became disengaged into the patient's mouth.Every swab undergoes a pull test to ensure the swab is securely attached, if the swab fails this test, it will be rejected.All production records indicated the product was manufactured to specification.Therefore, the cause of the foam disengagement could not be determined.No corrective actions were taken as a result of this investigation because the returned product was manufactured to specification and the root cause of the reported complaint could not be determined.Complaints relating to swab disengagements will continue to be monitored and trended.
 
Event Description
It was reported that a piece of the foam from a sage single use oral swab became disengaged inside a patient's mouth during initial use of the device.The nurse did not know the cause of the foam disengagement.However, she stated the patient did not bite the swab.The patient was sedated, not alert or oriented and had an endotracheal tube in place.The nurse was able to remove the disengaged piece of foam from the patient¿s mouth with her fingers after the endotracheal tube was moved to the other side.There was no adverse consequence or clinically relevant delay in treatment related to this event.Although requested, no further information was available.Awaiting product return.
 
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Brand Name
TOC PLS BCRB-20PK 1000
Type of Device
SINGLE USE 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 Key16587729
MDR Text Key312203770
Report Number0001419181-2023-00001
Device Sequence Number1
Product Code KXF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/28/2023
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 Model Number6076
Device Catalogue Number6076
Device Lot Number89536
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device Age6 MO
Event Location Hospital
Initial Date Manufacturer Received 02/22/2023
Initial Date FDA Received03/21/2023
Supplement Dates Manufacturer Received02/22/2023
Supplement Dates FDA Received04/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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