MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; 1LYR 16FR 10ML 100%SILI UM TRAY

Model Number	DYND160816
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported; "the foley balloon disintegrated." email received by (b)(6), critical care supervisor, (b)(6) hospital who simply states in response to the incident, "a new foley was reinserted and no further treatment was necessary." there was no report of the nurse experiencing issues inflating the balloon or anything unique about the patient or the case that could have motivated the incident.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No sample has been return for evaluation.Without a sample, a root cause will be difficult if not impossible to determine.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.
Event or Problem Description
It was reported; "the foley balloon disintegrated." a new foley catheter was reinserted.

• Brand Name: MEDLINE
• Common Device Name: 1LYR 16FR 10ML 100%SILI UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12550189
• Report Number: 1417592-2021-00183
• Device Sequence Number: 14275074
• Product Code: OHR
• UDI-Device Identifier: 10884389286296
• UDI-Public: 10884389286296
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: Health Professional
• Device Model Number: DYND160816
• Device Catalogue Number: DYND160816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention