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

Model Number	DYND160806
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported, on (b)(6) 2023, "after the child was placed in the crib i walked around to the other side to do his assessment and the realized the catheter was no longer attached.Urine was flowing out of the catheter, so i removed the catheter from where it was secured to his leg and placed it in a diaper." the catheter was replaced the same day due to the reported incident.The customer reports no serious injury related to the incident.It was reported that the patient has been discharged home.A sample was returned and the defect was confirmed.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Catheter ripped requring replacement.

• Brand Name: Medline
• Common Device Name: 1LYR 6FR1.5ML 100%SILI PEDS TR
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16488508
• Report Number: 1417592-2023-00088
• Device Sequence Number: 5912335
• Product Code: OHR
• UDI-Device Identifier: 10884389118900
• UDI-Public: 10884389118900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2023

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
• Device Model Number: DYND160806
• Device Catalogue Number: DYND160806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male