MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; CATHETER,FOLEY,100% SILICONE,8FR,3ML,LF

Model Number	DYND11553
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility the catheter was dislodged from the patient, 'and the balloon appeared to have burst'.Per the facility an additional catheter was placed and no serious injury occurred.The sample is reported to be available but has not been returned for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility the catheter was dislodged from the patient, 'and the balloon appeared to have burst'.Per the facility an additional catheter was placed and no serious injury occurred.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,100% SILICONE,8FR,3ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15411248
• Report Number: 1417592-2022-00162
• Device Sequence Number: 6744238
• Product Code: EZL
• UDI-Device Identifier: 10080196848836
• UDI-Public: 10080196848836
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: DYND11553
• Device Catalogue Number: DYND11553
• Device Lot Number: 59221122402
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown