MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,SILI-ELAST,LTX,16FR,10ML

Catalog Number	DYND11756H
Health Effect - Clinical Codes	Urinary Retention (2119); Urinary Tract Infection (2120)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a customer with chronic urinary retention was having his monthly suprapubic catheter replaced by his family caregiver who reported that the balloon of the catheter inflated on the wrong end of the catheter.The caregiver reportedly removed the catheter from the end user but did not have any catheters left to attempt to replace the catheter with a new catheter.After two hours of attempting to locate another catheter the customer was taken to the emergency department where a urologist inserted a catheter, drained 750cc of urine from the customer's bladder and secured a new catheter without difficulty.The customer was discharged home and instructed to follow up with his primary care physician.The customer was seen by his primary care physician for a follow up appointment and the physician diagnosed the end user with a urinary tract infection (uti).The customer was started on oral cipro 250mg twice daily for 7 days with no further discharge instructions noted.No additional details are available.The sample has not been returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the foley catheter balloon would not properly inflate resulting in the catheter not securing and the end user experiencing urinary retention.
Additional Manufacturer Narrative
Patient's age: 90 years old.Initial report received by manufacturer: 10/3/2019.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,16FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9191949
• Report Number: 1417592-2019-00172
• Device Sequence Number: 3104300
• Product Code: EZL
• UDI-Device Identifier: 10080196726523
• UDI-Public: 10080196726523
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: Other
• Device Catalogue Number: DYND11756H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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