MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; KIT,SPECI-CATH,NEO,5FR,9IN,PVP,LUB,GLV

Model Number	DYND10820
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, a patient was catheterized an additional time due to a report of a malfunction in a catheter.Email received by (b)(6), whom provided additional information in regards to this incident.Reporter states, on (b)(6) 2021 medline ref dynd10820 neonatal 5fr.9in.Speci-cath kit was utilized to catheterize a three-month old infant for the purposes of obtaining a urine specimen.It was reported, "i was pulling the tube out the urine began to either go back up into the patient or leaked out from the plastic catheter from the top of the catheter.After the catheter was completely pulled away from the patient, the urine continued to be pulled up from the urine container by the catheter and out of the container.The catheter was not near the level of the urine.It appeared to me like the urine was siphoning back out of the tube by a creation of a vacuum.Unsure what really happened but wanted to report that the equipment i used definitely malfunctioned.This patient was cathed again and was cathed with the same equipment and lot number but it did not malfunction the second time." reporter states, no samples are available for return and evaluation.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.
Event or Problem Description
It was reported, a patient was catheterized an additional time due to a report of a malfunction in a catheter.

• Brand Name: MEDLINE
• Common Device Name: KIT,SPECI-CATH,NEO,5FR,9IN,PVP,LUB,GLV
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12647117
• Report Number: 1417592-2021-00184
• Device Sequence Number: 19222020
• Product Code: OHR
• UDI-Device Identifier: 10080196028894
• UDI-Public: 10080196028894
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: DYND10820
• Device Catalogue Number: DYND10820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/18/2021
• 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: 3 MO
• Patient Weight: 6