MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; CATHETER,FOLEY,100%SILICONE,16FR,10ML,LF

Model Number DYND11502

Device Problems Material Rupture (1546); Device Fell (4014)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that a patient was inpatient in the hospital for an unreported reason with a history of chronic renal failure, dementia, parkinson's disease and behavioral disturbances.Verbal information from the morning nurse relayed that the catheter was found dislodged while the patient was in bed, calm.The balloon was found completely deflated.There was no reported trauma or injury to the patient.The nurse reported that a new catheter was reinserted.The actual sample was disposed of and is not available to be returned for evaluation.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the balloon of the catheter became fully deflated and the catheter fell out of the patient shortly after being secured requiring a new catheter to be placed.

• Brand Name: MEDLINE
• Type of Device: CATHETER,FOLEY,100%SILICONE,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12024553
• MDR Text Key: 260230749
• Report Number: 1417592-2021-00106
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10884389034538
• UDI-Public: 10884389034538
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/18/2021

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
• Device Operator: Health Professional
• Device Model Number: DYND11502
• Device Catalogue Number: DYND11502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 42