MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 1LYR 6FR1.5ML 100%SILI PEDS TR

Catalog Number	DYND160806
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient came back from the operating room after an unknown procedure with a foley catheter in place.The bedside nurse took off the tegaderm that was securing the foley catheter to the patient's leg resulting in the foley catheter tubing being torn in half.The nurse was able to aspirate the balloon, remove the remainder of the catheter and place a new foley catheter without further incident.There was no injury reported.The actual sample was returned for evaluation.The reported issue of a foley catheter broken in half was confirmed through visual inspection of the received sample.There is no definitive root cause at this time; however, based on the appearance of the received sample and the initial customer report it is possible that an external force punctured the silicone material, leading to the catheter shaft breaking in two when tension was applied.No manufacturing defect was identified.Due to the reported incident and medical intervention, this medwatch is being filed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during the removal of tegaderm a foley catheter broke in half.

• Common Device Name: 1LYR 6FR1.5ML 100%SILI PEDS TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7122223
• Report Number: 1417592-2017-00084
• Device Sequence Number: 2037414
• Product Code: OHR
• UDI-Device Identifier: 10884389118900
• UDI-Public: 10884389118900
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 12/15/2017

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?: No
• Operator of Device: Nurse
• Device Catalogue Number: DYND160806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/15/2017
• 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