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

Model Number DYND11502

Device Problem Device Slipped (1584)

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

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that a (b)(6) year old male patient has been using foley catheters for chronic issues with urinary retention and experienced four issues in one week with the catheter dislodging and requiring replacement (this is report 2:4).The patient initially had the catheter placed on (b)(6) 2021 and it was noted on (b)(6) 2021 that the catheter dislodged with a deflated balloon.There was reportedly no inadvertent force applied to or against the catheter during use.A new catheter was placed without further incident.The patient is reportedly doing well at this time.The sample was discarded and not returned to the manufacturer for evaluation.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 Description

It was reported that the foley catheter kept slipping out of place requiring the catheter to be completely removed and replaced with a new catheter.

• 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: 11655449
• MDR Text Key: 256447301
• Report Number: 1417592-2021-00077
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 76 YR
• Patient Weight: 59