MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; CATHETER,FOLEY,SILI-ELAST,LTX,20FR,10ML

Model Number	DYND11760
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported via med watch report (number (b)(4)) a "patient underwent robotic prostatectomy.Patient discharged home with silastic foley catheter (date unknown).Patient presented to emergency department two and a half weeks post operatively (date unknown) after catheter balloon malfunctioned and catheter "slipped out (date unknown)." patient required foley catheter replacement via cystoscopy in the ed." the foley catheter replacement via cystoscopy date is unknown).Email received by risk management coordinator,(b)(6) hospital/(b)(6) children's hospital provided patient demographics.No additional details are available related to the customer reported issue.Despite good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Sample is not available for return and evaluation.Due to the sample unavailable for return a root cause will be difficult if not impossible to determine.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.
Event or Problem Description
It was reported via med watch report (number (b)(4)) a "patient underwent robotic prostatectomy.Patient was discharged home with silastic foley catheter.Patient presented to emergency dept.Two and a half weeks post op, after catheter balloon malfunctioned and catheter "slipped out." patient required foley catheter replacement via cystoscopy in the ed.".

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,20FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11827903
• Report Number: 1417592-2021-00093
• Device Sequence Number: 17052233
• Product Code: EZL
• UDI-Device Identifier: 10080196726547
• UDI-Public: 10080196726547
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DYND11760
• Device Catalogue Number: DYND11760
• Device Lot Number: 10 59220122557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 73