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

Catalog Number	DYND11803
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the customer was undergoing a transurethral resection of the prostate (turp) and when the catheter was put into place, the balloon inflated without incident however the surgeon was unable to irrigate the catheter through the in port.The surgeon was able to perform the process through the out port and drain the urine without impact to the procedure.The patient was moved to the recovery room and the surgeon had the catheter switched from the 22fr to a 24fr which was noted to be draining urine without further incident.The patient was upset about the additional catheterization procedure and was given a small dose of versed (exact dose not specified) prior to the procedure being performed however no serious injury was noted related to the reported event.The patient was discharged from the facility and was reportedly doing well.The sample has been discarded and is not available to be returned for evaluation.No additional information is available.Due to the reported incident, 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 the urinary catheter was unable to irrigate through the in port.The urinary catheter was removed and replaced.

• 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: 9569146
• Report Number: 1417592-2020-00001
• Device Sequence Number: 19521927
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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 Catalogue Number: DYND11803
• Device Lot Number: 59217122398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/09/2020
• 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: 104