MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. Medline; CATHETER,FOLEY,3WAY,SILI-ELAST,22FR,30ML

Model Number	DYND11803
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the end user was undergoing a cystoscopy and transurethral resection of the prostate (turp) and when the catheter was put into place, there was no leaking noticed from any area.The balloon of the catheter was filled with 30ml of sterile water.The catheter fell out approximately 3 to 5 minutes after insertion.The issue was noted when the nurse went to secure the catheter in place and he noticed it was no longer inserted.The doctor then inserted the catheter into place after the patient's cystoscopy & turp for continuous bladder irrigation.There was no harm or impact to the patient and no change in the patient's plan of care.The patient was unaware of the incident as he was still a sleep.A sample was returned for evaluation and the suspected root cause was determined to be an error in the manufacturing process.No additional information is available.Due to the need for medical intervention to replace the catheter and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a catheter fell out during a procedure and another catheter had to be placed.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,3WAY,SILI-ELAST,22FR,30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9683884
• Report Number: 1417592-2020-00010
• Device Sequence Number: 13599695
• Product Code: EZL
• UDI-Device Identifier: 10080196030347
• UDI-Public: 10080196030347
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: DYND11803
• Device Catalogue Number: DYND11803
• Device Lot Number: 592171205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 73