MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; CATHETER,FOLEY,COUDE,LATEX,16FR,10ML

Model Number	DYND11216
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient was using a foley catheter for short term purposes and after approximately 2 days of the catheter being in place the balloon on the foley catheter deflated.A new foley was reinserted without further issue reported.10 companion samples were returned from the customer to the manufacturer for evaluation.The reported issue of deflated foley catheter balloon could not be confirmed through visual, functional or dimensional evaluation of all samples received.All received samples were inflated with 10 ml of water and all catheters performed within specification.No additional information is available.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a patient was using a foley catheter for short term purposes and after approximately 2 days of the catheter being in place the balloon on the foley catheter deflated.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,COUDE,LATEX,16FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13040419
• Report Number: 1417592-2021-00221
• Device Sequence Number: 5449477
• Product Code: EZL
• UDI-Device Identifier: 10080196726769
• UDI-Public: 10080196726769
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND11216
• Device Catalogue Number: DYND11216
• Device Lot Number: 59221061191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female