MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. Medline; CATHETER,FOLEY,100%SILICONE,18FR,30ML,LF

Model Number	DYND11533
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the foley catheter balloon burst and had to be replaced.The customer reported the nurse was changing the catheter using a 30cc foley catheter, when it burst and came out.The nurse had to replace it with a 10cc and experienced difficulty re-inserting, due to prostate issues.No additional information was provided related to the reported incident.Due to the need for medical intervention and in an abundance of caution, this is an mdr reportable event.It was noted that a sample or photo was no longer available.Therefore, this specific sample could not be investigated for a definite root cause or any potential product quality issues.If additional relevant information becomes available a supplemental mdr will be filed.
Event or Problem Description
It was reported the foley catheter balloon burst and had to be replaced.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,100%SILICONE,18FR,30ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10181372
• Report Number: 1417592-2020-00072
• Device Sequence Number: 19059698
• Product Code: EZL
• UDI-Device Identifier: 10884389034552
• UDI-Public: 10884389034552
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND11533
• Device Catalogue Number: DYND11533H
• Device Lot Number: 59219102243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/22/2020
• 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: 87 YR