MAUDE Adverse Event Report: SAGE PRODUCTS LLC INTL QCARE Q4 SYS W/CORINZ 20; SUCTION ORAL SWAB

Catalog Number 6464-X

Device Problem Material Separation (1562)

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

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

The affected 6464-x oral care kit was returned, and two photos of the affected device were provided and reviewed.The photographs confirmed that the suction swab from lot 90927 had a detached swab head.The same device from the photographs was returned and inspected and confirmed the suction swab head was detached from the product.Additionally, the end of the stick was not a clean-cut slice and appeared to be rigid as if it was broken or snapped off.The remaining stick was still secured in the middle of the swab head; therefore, the presence of glue was confirmed.The remaining stick inside the suction swab head also confirmed that the suction swab device was broken off and therefore was not a manufacturing defect.Product history records were reviewed and showed 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.

Event Description

Report received of a suction oral swab disengagement that occurred on(b)(6) 2023.Reporter stated that when a nurse was going to push the liquid out of the burst pouch contained in the 6464-x package, the suction oral swab became disengaged.The reporter stated that this occurred on an unused oral care kit prior to use on the patient.No adverse consequences were reported.The reporter provided pictures and the product was returned for evaluation.Although requested no additional information was available.

Event Description

Report received of a suction oral swab disengagement that occurred on (b)(6) 2023.Reporter stated that when a nurse was going to push the liquid out of the burst pouch contained in the 6464-x package, the suction oral swab became disengaged.The reporter stated that this occurred on an unused oral care kit prior to use on the patient.No adverse consequences were reported.The reporter provided pictures and the product was returned for evaluation.Although requested no additional information was available.

Manufacturer Narrative

Udi-di was inadvertently omitted in previous submission.

• Brand Name: INTL QCARE Q4 SYS W/CORINZ 20
• Type of Device: SUCTION 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: 17881602
• MDR Text Key: 325073058
• Report Number: 0001419181-2023-00007
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6464-X
• Device Lot Number: 90927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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