MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,SILI-ELAST,LTX,20FR,30ML

Catalog Number	DYND11780
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was initially reported that an unidentified number of foley catheters are "clogging very quickly" requiring replacement twice in a shift.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural/event details.The date/s of the incident is unknown.There was no serious injury originally reported related to the incident/s.Due to the reported intervention of exchanging the foley catheters, this medwatch is being filed.A sample is not available to be returned for evaluation.A definitive root cause could not be determined 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 an unidentified number of foley catheters are "clogging very quickly" requiring replacement twice in a shift.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,20FR,30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8495264
• Report Number: 1417592-2019-00044
• Device Sequence Number: 1884796
• Product Code: EZL
• UDI-Device Identifier: 10080196726608
• UDI-Public: 10080196726608
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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: DYND11780
• Device Lot Number: 59218050659
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/09/2019
• 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