MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; CATHETER,FOLEY,100%SILICONE,14FR,10ML,LF

Model Number	DYND11501
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility the "catheter bulb had broken and pieces of the bulb were seen in the tubing while in the patient".Per the facility the foley catheter was removed from the patient.No additional information is available.Sample is not available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 bulb had broken and pieces of the bulb were seen in the tubing while in the patient".

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,100%SILICONE,14FR,10ML,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: 17317778
• Report Number: 1417592-2023-00291
• Device Sequence Number: 17698755
• Product Code: EZL
• UDI-Device Identifier: 10884389034439
• UDI-Public: 10884389034439
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/13/2023

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
• Device Model Number: DYND11501
• Device Catalogue Number: DYND11501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 07/13/2023
• 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: Other
• Patient Sex: Unknown