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

Model Number	DYND160806
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, on the date of incident ((b)(6) 2020), the urinary catheter that was inserted on (b)(6) 2020 tore at the shaft.When the tear was identified, the device was "immediately clamped and removed." reportedly, the tip of the urinary catheter remained within the patient after the tear.The urinary catheter tip was successfully retrieved without incident via an unspecified method.After the incident, a new urinary catheter was reported inserted into patient.The reporting facility indicated that there was no adverse impact to the patient.A sample was returned to the manufacturer for evaluation.Visual inspection identify that the urinary catheter was severed at the midway point along the shaft.The break line on the shaft showed no signs of indentations, material degradation, or variance in wall thickness.The cut was smooth, even, and split with no jagged characteristics.The tip of the urinary catheter was not returned to the manufacturer for evaluation.Although a definitive root cause was unable to be determined it is possible that an external tensile force applied to the shaft of the catheter may have caused or contributed to the tear.Due to the reported need for medical intervention to retrieve the urinary catheter tip and insert a new 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 shaft tore while the urinary catheter was inserted in the patient.

• Brand Name: Medline
• Common Device Name: 1LYR 6FR1.5ML 100%SILI PEDS TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9717841
• Report Number: 1417592-2020-00011
• Device Sequence Number: 3129286
• Product Code: EZL
• UDI-Device Identifier: 10884389118900
• UDI-Public: 10884389118900
• Combination Product (Y/N): N
• 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): 02/17/2020

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: DYND160806
• Device Catalogue Number: DYND160806
• Device Lot Number: 592171202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/17/2020
• 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: 1 YR
• Patient Weight: 10