MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; CATHETER,FOLEY,SIL-ELAST,LATEX,6FR,1.5ML

Model Number	DYND11706
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported to the manufacturer via medwatch (b)(4), that a pediatric foley catheter was placed into a patient prior to surgery start and at the end of the procedure, as the foley was being removed, the foley broke into pieces within the patient.The facility reported that the pieces of the foley remained in the patient resulting in the patient being transferred to another hospital for removal of the retained object.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 samples have been returned for evaluation.Due to the reported incident and in an abundance of caution, 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 catheter was put in place prior to surgery and after the surgical procedure, during catheter removal, the foley broke into pieces within the patient requiring surgical intervention.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,SIL-ELAST,LATEX,6FR,1.5ML
• 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: 13059651
• Report Number: 1417592-2021-00227
• Device Sequence Number: 17121565
• Product Code: EZL
• UDI-Device Identifier: 10080196726479
• UDI-Public: 10080196726479
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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: DYND11706
• Device Catalogue Number: DYND11706
• Device Lot Number: 496826R001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Male