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

Catalog Number DYND11503

Device Problem Gas/Air Leak (2946)

Patient Problem No Code Available (3191)

Event Date 10/09/2019

Event Type  malfunction  

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 Description

It was reported that the foley catheter's balloon spontaneously deflated and end-user required a new foley catheter inserted.

• Type of Device: CATHETER,FOLEY,100%SILICONE,18FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 9295596
• MDR Text Key: 190758369
• Report Number: 1417592-2019-00197
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10080196845460
• UDI-Public: 10080196845460
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND11503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 100