MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,SILI-ELAST,LTX,20FR,10ML

Catalog Number	DYND11760
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter's balloon deflated after being in place for "1 day." reportedly, when the balloon deflation was identified, the urinary catheter was removed and replaced.No serious injury, follow-up care, or impact to the patient's stability was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the need for medical intervention to replace the urinary catheter, 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's balloon deflated and it was required to be replaced.
Additional Manufacturer Narrative
The manufacturer received three samples in unused and packaged condition from the reporting facility.Visual inspection of the received samples revealed no noted product defects or abnormalities.Functional evaluation was performed by inflating all urinary catheter balloons with approximately 10ml of water.At full inflation, pressure was applied to all urinary catheter balloons and no leakage was identified.All urinary catheter balloons were able to inflate and deflate fully with no noted defects or abnormalities.A root cause for the reported incident could not be determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,20FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8213643
• Report Number: 1417592-2018-00146
• Device Sequence Number: 16195927
• Product Code: EZL
• UDI-Device Identifier: 10080196726547
• UDI-Public: 10080196726547
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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 Catalogue Number: DYND11760
• Device Lot Number: 1304020265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/17/2019
• 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
• Patient Age: 87 YR
• Patient Weight: 68