MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; TRAY,FOLEY,SILVER,2-WAY,18FR,10ML,LF

Model Number	DYND140218
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the facility that the catheter, 'adheres to the tissue causing painful removal and tissue damage' resulting in another catheter being reinserted.
Additional Manufacturer Narrative
It was reported by the facility that the catheter, 'adheres to the tissue causing painful removal and tissue damage' resulting in another catheter being reinserted.According to the facility the catheter was placed on (b)(6) 2022 and was required for acute care.Per the facility the catheter was inserted in the patient less than 30 minutes.During routine catheter removal the catheter balloon was deflated but 'adhered to the inside of the patient's anatomy'.According to the facility there was no previous patient history of urinary tract infection but upon removal there was noted bleeding from the urethra and urinary retention noted which led to another catheter being reinserted.No additional patient injury or medical intervention reported.The patient was discharged from the facility on (b)(6) 2022.The sample was not returned for evaluation.No additional information is available.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.

• Brand Name: Medline
• Common Device Name: TRAY,FOLEY,SILVER,2-WAY,18FR,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: 13685792
• Report Number: 1417592-2022-00029
• Device Sequence Number: 20066198
• Product Code: OHR
• UDI-Device Identifier: 10080196183401
• UDI-Public: 10080196183401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND140218
• Device Catalogue Number: DYND140218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/08/2022
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 120 KG