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

Model Number	DYND11778
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter balloon was unable to be deflated by the home health nurse after several attempts and after contacting the urologist, the nurse instructed end user to go to the emergency room (er).That same day (b)(6) 2020, the end user was met in the er by her urologist's nurse practioner, who attempted several times to remove the foley catheter.It was reported that the urinary catheter balloon was unable to be deflated.The end user reports, "a needle was inserted through her vagina and the balloon was deflated in that manner, and the catheter removed".A new urinary catheter was inserted and no further incident was reported to the manufacturer.The sample was discarded at the hospital therefore; there is no sample for return and evaluation.A root cause for the reported product problem/issue will not be able to be determined.Due to the need for medical intervention during the reported incident, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the urinary catheter balloon was unable to be deflated.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,18FR,30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10125227
• Report Number: 1417592-2020-00062
• Device Sequence Number: 11322877
• Product Code: EZL
• UDI-Device Identifier: 10080196726592
• UDI-Public: 10080196726592
• Combination Product (Y/N): N
• 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): 06/05/2020

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: DYND11778
• Device Catalogue Number: DYND11778
• Device Lot Number: 59219102241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/05/2020
• 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: Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 95