MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE CHG 0.12% ORAL RINNSE KIT; ORAL SUCTION SWAB/APPLICATOR ABSORBED TIPPED STERILE

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2018

Event Type  Injury  

Event Description

Medline chg 0.12% oral rinse oral care kit suction/swab broke off at adaptor site, plastic snapped completely disconnecting the suction adaptor from the swab.This occurred during mouth care.Attempted a second swab and the same thing occurred.No patient harm occurred, this did not occur with the tooth brush swab.

• Brand Name: MEDLINE CHG 0.12% ORAL RINNSE KIT
• Type of Device: ORAL SUCTION SWAB/APPLICATOR ABSORBED TIPPED STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; mundelein IL 60060
• MDR Report Key: 7929910
• MDR Text Key: 122800732
• Report Number: MW5080304
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 10888277318625
• UDI-Public: (01)10888277318625
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR