MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,SILI-ELAST,LTX,16FR,30ML

Catalog Number DYND11776

Device Problem Material Discolored (1170)

Patient Problem Unspecified Infection (1930)

Event Date 10/01/2019

Event Type  Injury  

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 an early manufacturing date greater that five (5) years prior to the suspected date of use.As the urinary catheter is more than five (5) years old, it may have been subjected to environmental conditions, such as storage and handling, which may have degraded the product or compromised its sterility and contributed to the reported incident.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 Description

It was reported that the urinary catheter was discolored and that a patient experienced an infection.

• Type of Device: CATHETER,FOLEY,SILI-ELAST,LTX,16FR,30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9310068
• MDR Text Key: 165998584
• Report Number: 1417592-2019-00188
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10080196726585
• UDI-Public: 10080196726585
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND11776
• Device Lot Number: 495612R001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other