MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP CATHETER,FOLEY,100% SIL,COUDE,18FR 10ML

Model Number	DYND11593
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported that the physician inserted a a coude 18fr silicone and the tip punctured patient's bladder.The patient is reportedly ok.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.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
The facility reported that the physician inserted a coude 18fr silicone and the tip punctured patient's bladder.

• Brand Name: CATHETER,FOLEY,100% SIL,COUDE,18FR 10ML
• Common Device Name: CATHETER,FOLEY,100% SIL,COUDE,18FR 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: 14686015
• Report Number: 1417592-2022-00075
• Device Sequence Number: 5538875
• Product Code: EZL
• UDI-Device Identifier: 10884389124024
• UDI-Public: 10884389124024
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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: Lay User/Patient
• Device Model Number: DYND11593
• Device Catalogue Number: DYND11593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/14/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown