MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,100%SILICONE,18FR,10ML,LF

Catalog Number	DYND11503
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a day after insertion of the foley catheter, the foley catheter's balloon spontaneously deflated resulting in the foley catheter falling off from being inserted in the patient.The incident was reportedly noted while end-user was being changed and cleaned by end user's home health aide.The foley catheter was reportedly inserted by end user's home health nurse.It was reported by the end-user that another foley catheter was inserted after the previously mentioned foley catheter fell off.The end user added that he has been experiencing "burning pain" and his urine was sent to be checked for urinary tract infection.Per report, results has not been relayed to the end user at this time.It was denied that end user was prescribed with any medications related to this incident.Due to the reported foley catheter balloon deflating which required foley catheter re-insertion, this medwatch is being filed.The sample has been discarded and is not available to be returned for evaluation.A definitive root cause for the reported issue could not be determined.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the foley catheter's balloon spontaneously deflated and end-user required a new foley catheter inserted.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,18FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9295596
• Report Number: 1417592-2019-00197
• Device Sequence Number: 2408722
• Product Code: EZL
• UDI-Device Identifier: 10080196845460
• UDI-Public: 10080196845460
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2019

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: DYND11503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/08/2019
• 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
• Patient Age: 76 YR
• Patient Weight: 100