MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 1LYR 18FR 10ML 100%SILI DB TRA

Catalog Number	DYND160718H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the balloon of the foley catheter burst resulting in the foley catheter falling from being inserted in patient.Per report, the incident was noted after patient was noticed with a distended bladder and foley catheter was then found laying in between the patient's legs.The reporter stated that she tried to re-inflate the balloon and she noted that the balloon had burst.The foley catheter was reportedly inserted five days prior to the date of this incident.After the foley catheter was noted out, the reporter's brother-in-law (who reportedly is a physician) took a replacement foley catheter from his work and another foley catheter was inserted in patient.There was no report of a need for medical evaluation and/or treatment related to this incident.Due to the reported foley catheter bursting and the need for foley catheter replacement, this medwatch is being filed.The sample is not available to be returned for evaluation.The lot number is unavailable.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 balloon of the foley catheter burst resulting in the foley catheter falling from being inserted in patient.Patient required another foley catheter insertion.

• Common Device Name: 1LYR 18FR 10ML 100%SILI DB TRA
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9375961
• Report Number: 1417592-2019-00208
• Device Sequence Number: 2423456
• Product Code: OHR
• UDI-Device Identifier: 10884389235140
• UDI-Public: 10884389235140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/26/2019

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: DYND160718H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/26/2019
• 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