MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; CATHETER,FOLEY,SILI ELAST,LTX,16FR,10ML

Model Number	DYND11756
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 a catheter was placed by the rn for a patient in the home setting.At some point, the on call rn was called due to the catheter leaking.At this time, a new catheter was placed.The patient requires the catheter for a chronic condition.No other details were available regarding the reported event.The sample is not available to be returned for evaluation.It has been determined that the reported event required medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Catheter leaked requiring additional catheter to be placed.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,SILI ELAST,LTX,16FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16279913
• Report Number: 1417592-2023-00039
• Device Sequence Number: 6973060
• Product Code: EZL
• UDI-Device Identifier: 10080196726523
• UDI-Public: 10080196726523
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/01/2023

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: DYND11756
• Device Catalogue Number: DYND11756H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/01/2023
• 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: Male