MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TOTAL TRAY, DB, 100% SILI FOLEY, 16FR 10

Catalog Number URO170716

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/24/2022

Event Type  Injury  

Event Description

According to the facility associate a foley catheter became dislodged and a new foley catheter had to be placed.

Manufacturer Narrative

According to the facility associate, a foley catheter became dislodged and a new foley catheter had to be place.According to the facility a foley catheter was placed in a patient for chronic urinary retention.Per the facility, 'the registered nurse was turning the patient for cleaning and the foley was observed to have slid out of the patient's urethra during the turn'.The registered nurse assessed the catheter and found the balloon to no longer 'be intact'.According to the facility all pieces of the catheter were accounted for and an abdominal ultrasound was performed.A new catheter was then placed without complication and the patient was discharged the same day.The sample has been returned and the customer reported issue was confirmed, however, a definitive root cause could not be determined at this time.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.

• Type of Device: TOTAL TRAY, DB, 100% SILI FOLEY, 16FR 10
• 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: 13872909
• MDR Text Key: 287788060
• Report Number: 1417592-2022-00035
• Device Sequence Number: 1
• Product Code: OHR
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO170716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Female