MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,SILI-ELAST,LTX,18FR,30ML

Catalog Number	DYND11778
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that after the foley catheter was inserted in the patient, the foley catheter's balloon broke during inflation.Per report, at the time of the incident, the nurse was very cautious and did not overinflate or placed additional volume within the maximum recommended for the balloon.Reportedly, the foley catheter with broken balloon was pulled out from the patient and another foley catheter was inserted.Despite good faith efforts to obtain additional information, the initial reporter was unable or unwilling to provide any further patient, product, or procedural details.There was no serious injury or follow-up care reported related to this event.No further medical intervention or testing was required.Due to reported event and need for foley catheter re-insertion, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause could not be determined at this time.It was noted that the catheters were stored for over a year before use; it is not known if improper storage conditions may have contributed to the reported issue.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that after the foley catheter was inserted in the patient, the foley catheter's balloon broke during inflation.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,18FR,30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8479698
• Report Number: 1417592-2019-00041
• Device Sequence Number: 1761469
• Product Code: EZL
• UDI-Device Identifier: 10080196726592
• UDI-Public: 10080196726592
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: DYND11778
• Device Lot Number: 59217112048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/03/2019
• 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: Other; Required Intervention