MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC SOS W/PROX 100; SUCTION SWAB

Model Number	6512
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter stated that the involved product was discarded, however provided lot information and returned forty-nine (49) same lot sample packages.Product #6512 contains two (2) suction oral swabs.All ninety-eight (98) suction oral swab were inspected and foam heads were subjected to pull testing to confirm proper swab head adherence.All ninety-eight (98) suction oral swabs passed testing and showed no signs of foam head disengagement.Based upon the evaluation, returned product met all criteria and was within specification.Production history records for the reported lot number were reviewed and all in-process checks indicated passing results.No anomalies were identified during production of the product.The root cause for the reported issue could not be determined.Based on the lack of information, evaluation of same lot samples and review of product history records, there is insufficient evidence to conclude that the reported issue was attributable to a product defect or manufacturing operations.Customer discarded; same lot samples provided.
Event or Problem Description
Report received of a malfunction resulting in suction swab foam disengagement.On (b)(6) 2018, a distributor received a report that foam fell off the top of the suction oral swab.The distributor's report states no injury occurred.Multiple attempts to obtain further information were unsuccessful.The distributor reported that the involved product was discarded; however, same lot samples were returned for evaluation.Although requested, no additional information was available.

• Brand Name: TOC SOS W/PROX 100
• Common Device Name: SUCTION SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 7536555
• Report Number: 0001419181-2018-00019
• Device Sequence Number: 945253
• Product Code: JOL
• UDI-Device Identifier: 50618029800638
• UDI-Public: 50618029800638
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/14/2020
• Device Model Number: 6512
• Device Catalogue Number: 6512
• Device Lot Number: 64902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1