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

Model Number DYND11760

Device Problems Device Slipped (1584); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

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 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
• Type of Device: CATHETER,FOLEY,SILI-ELAST,LTX,20FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11827903
• MDR Text Key: 253706275
• Report Number: 1417592-2021-00093
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10080196726547
• UDI-Public: 10080196726547
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DYND11760
• Device Catalogue Number: DYND11760
• Device Lot Number: 10 59220122557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 73