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

Model Number	DYND11706
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medwatch was received in a paper format via mail from the fda and delivered to an unattended mailbox due to covid-19 workplace policy restrictions.Upon discovery the report was investigated per procedure and the mail receiving process has been modified.User facility medwatch number: (b)(4).It was reported that the catheter was placed prior to a voiding cystourethrogram study.The catheter was inserted with ease with good urine return.The balloon was filled with 3ml of sterile water and the catheter was connected to a leg bag.While in radiology the catheter was detached from the bag and attempted to flush prior to inserting contrast.The catheter would not flush or return urine.The clinician attempted to deflate the balloon to remove the catheter and the tubing, would collapse but no fluid would return.Finally, a stylet was attempted to pass through and would not pass.The catheter was cut, the balloon self-deflated and the catheter came out.The sample was not returned to the manufacturer for evaluation.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.A definitive root cause was not able to be determined.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.
Event or Problem Description
It was reported that the catheter was placed without difficulty however when attempting to flush the catheter the catheter would not flush or return urine.The balloon would not deflate and ultimately the catheter was cut, the balloon self-deflated and the catheter came out.

• Brand Name: CATHETER,FOLEY,SIL-ELAST,LATEX,6FR,1.5ML
• 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: 14690600
• Report Number: 1417592-2022-00078
• Device Sequence Number: 6693048
• Product Code: EZL
• UDI-Device Identifier: 10080196726479
• UDI-Public: 10080196726479
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND11706
• Device Catalogue Number: DYND11706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• 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: Required Intervention
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Race: White