MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER, IV, SURESITE AUTO, 20G X 1.00

Catalog Number	DYNA20100Z
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility "when inserted into the vein to start the iv, it sticks to the needle and does not result in a smooth extraction of the needle from the catheter.Multiple patients were involved.The patients ae fine".The customer confirmed that patients has to be re- stuck with a new iv start attempt.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
According to the facility "when inserted into the vein to start the iv, it sticks to the needle and does not result in a smooth extraction of the needle from the catheter.".

• Common Device Name: CATHETER, IV, SURESITE AUTO, 20G X 1.00
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20578507
• Report Number: 1417592-2024-00930
• Device Sequence Number: 8170561
• Product Code: FOZ
• UDI-Device Identifier: 20193489140108
• UDI-Public: 20193489140108
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/31/2024

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 Catalogue Number: DYNA20100Z
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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