MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS MEDLINE; POLY MIDLINE KIT 4F SL

Model Number	DYNJ68937A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the catheter kinked and the account was unable to obtain any blood return.The sample was returned with a note that stated "took out of patient.Line was kinked in "l" shape.Wouldn't draw or flush.' no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was returned and forwarded to the vendor for evaluation.Due to the reported incident and 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
It was reported that the catheter kinked and the account was unable to flush the device or obtain any blood return which required cather removal.

• Brand Name: MEDLINE
• Common Device Name: POLY MIDLINE KIT 4F SL
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 3310 s main st; salisbury NC 28147
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13253766
• Report Number: 1038445-2022-00002
• Device Sequence Number: 11895406
• Product Code: LRS
• UDI-Device Identifier: 10193489111545
• UDI-Public: 10193489111545
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/13/2022

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: DYNJ68937A
• Device Catalogue Number: DYNJ68937A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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: Unknown