MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,COUDE,LATEX,18FR,10ML

Catalog Number	DYND11218
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was initially reported that foley catheters were clogging with sediments requiring frequent than usual foley catheter changes.Per report, these sediments that clog at the cuff make it "impossible to deflate or flush." despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.Due to the reported event and required foley catheter changes, this medwatch is being filed.The sample is not available to be returned for evaluation.A definitive root cause could not be identified at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that foley catheters were clogging with sediments requiring frequent than usual foley catheter changes.

• Common Device Name: CATHETER,FOLEY,COUDE,LATEX,18FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8637900
• Report Number: 1417592-2019-00078
• Device Sequence Number: 11285459
• Product Code: EZL
• UDI-Device Identifier: 10080196726776
• UDI-Public: 10080196726776
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 05/23/2019

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: DYND11218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/23/2019
• 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: Required Intervention