MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; CATHETER,FOLEY,TEMP SENS,16FR 10ML,LF

Model Number	DYND110516
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by (b)(6), sales representative, medline industries, inc., who provided additional information in regards to this reported incident.It was reported, the balloon broke on a foley catheter.Reporter states, date of incident (b)(6) 2021.Reporter states, foley catheter was placed two-weeks prior due to patient being comatose.Reportedly, the full 10mls of water in the water syringe from medline dynd110516 kit was used to inflate the balloon.No issues were experienced inflating the balloon.Nothing unique about the patient or the case was reported that could have motivated the reported incident.Reporter states, "foley slid out after insertion." a second foley catheter was placed without incident and the patient continues to be in the intensive care unit (icu).The sample has not been returned as of the date of this report.Without a sample or pictures, a root cause will likely be difficult or 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 balloon broke on a foley catheter.

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,TEMP SENS,16FR 10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12556117
• Report Number: 1417592-2021-00178
• Device Sequence Number: 11684371
• Product Code: EZL
• UDI-Device Identifier: 10884389122976
• UDI-Public: 10884389122976
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: DYND110516
• Device Catalogue Number: DYND110516
• Device Lot Number: 59221020212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/30/2021
• 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