MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,IV,SURESITE SLIDE,24G X 3/4

Catalog Number	DYNSCS24340Z
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported, the needle was withdrawn from the vein and it was noted that the catheter "puckered" under the skin which "caused the access site to blow".Due to this, the needle and catheter were removed.It was noted at the time that the "needle severed the plastic catheter".The iv catheter was removed and a new site was obtained.It was reported that no part of the needle or catheter was retained in the patient and the parts were intact on removal.No serious injury was reported related to the incident.A sample was requested to be returned for evaluation.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
Iv catheter was splintered and inserted into patient.

• Common Device Name: CATHETER,IV,SURESITE SLIDE,24G X 3/4
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17492164
• Report Number: 1417592-2023-00332
• Device Sequence Number: 7376893
• Product Code: FOZ
• UDI-Device Identifier: 10888277667556
• UDI-Public: 10888277667556
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/09/2023

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 Catalogue Number: DYNSCS24340Z
• Device Lot Number: 27821090011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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