MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,3WAY,SILI-ELAST,18FR,30ML

Catalog Number	DYND11801
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the urinary catheter was discolored and that a patient experienced an infection.Despite multiple good faith attempts the reporting facility was unable or unwilling to provide additional information to the manufacturer.No sample was returned to the manufacturer for evaluation.Although a definitive root cause was unable to be determined, a review of the reported lot number indicated that the urinary catheter was manufactured in 2004.Between 2004 and 2019 the urinary catheter may have been subjected to environmental conditions, such as storage and handling, which may have degraded the product or compromised its sterility.Due to the reported patient infection, 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 the urinary catheter was discolored and that a patient experienced an infection.

• Common Device Name: CATHETER,FOLEY,3WAY,SILI-ELAST,18FR,30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9309765
• Report Number: 1417592-2019-00187
• Device Sequence Number: 380409
• Product Code: EZL
• UDI-Device Identifier: 10080196030309
• UDI-Public: 10080196030309
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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: DYND11801
• Device Lot Number: 2004-E-02R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/12/2019
• 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: Other