MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TRAY, 1LYR 16FR 10ML LATEX URN METER

Model Number	DYND160216
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the end user was using a catheter to improve comfort during end of life care.While inserting the catheter the nurse noticed that the balloon was not inflating and appeared to be leaking.When the nurse found the catheter to be leaking the nurse removed the catheter and inserted a new catheter.There was no serious injury noted.The sample was discarded and is not available to be returned for evaluation.No additional information is available.Due to 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 while inserting the catheter the nurse noticed that the balloon was not inflating and appeared to be leaking.The nurse removed the catheter and inserted a new catheter.

• Brand Name: MEDLINE
• Common Device Name: TRAY, 1LYR 16FR 10ML LATEX URN METER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11682238
• Report Number: 1417592-2021-00081
• Device Sequence Number: 16924472
• Product Code: OHR
• UDI-Device Identifier: 10884389287705
• UDI-Public: 10884389287705
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND160216
• Device Catalogue Number: DYND160216
• Device Lot Number: 20IBE429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/16/2021
• 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: 74 YR
• Patient Weight: 103