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

Model Number DYND11593

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/01/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 293952856
• Report Number: 1417592-2022-00075
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10884389124024
• UDI-Public: 10884389124024
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DYND11593
• Device Catalogue Number: DYND11593
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other