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

Model Number 6075

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter discarded the involved product and did not provide photographs or lot information.Due to the lack of lot information, a product history record could not be reviewed.Reporter stated approximately half of the green foam remained on the swab handle.This would indicate that the foam head was glued to the swab handle appropriately.Reporter stated the patient was (b)(6), and while unsupervised, bit down on the green foam causing it to disengage.Per packaging instructions, it states, ¿use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Children under 12 years of age should be supervised in the use of the product¿.The root cause of the reported condition could be attributed to user error related to biting performed by the young unsupervised child.

Event Description

Report received of foam disengagement due to biting.The reporter advised the product was in the house from a family member's recent hospital stay.Reporter stated the green swabs were not intended to be used on his son.Reporter stated on (b)(6) 2019, his son was unsupervised and opened the green swab thinking it was a lollipop.Reporter stated his son bit off the top half of the green foam and swallowed it.Reporter stated foam could not be located in his son's mouth and his son did not appear to be in any respiratory or gastrointestinal distress.Reporter stated the white stick remained intact with half of the un-bitten foam still adhered to the stick.Reporter stated his son was not injured and the green foam was found in his feces on (b)(6) 2019.The involved device was discarded and no photographs or lot information were available.Although requested, no additional information provided.

• Brand Name: TOC PLS BCRB-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: heather sirianni ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 8376519
• MDR Text Key: 139567560
• Report Number: 0001419181-2019-00002
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2019

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: Lay User/Patient
• Device Model Number: 6075
• Device Catalogue Number: 6075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/27/2019
• 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
• Patient Age: 2 YR