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

Catalog Number DYNSCS24340Z

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

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The customer reported, the needle was withdrawn from the vein and it was noted that the catheter "puckered" under the skin which "caused the access site to blow".Due to this, the needle and catheter were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 Description

Iv catheter was splintered and inserted into patient.

• Type of Device: 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
• MDR Text Key: 320753961
• Report Number: 1417592-2023-00332
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10888277667556
• UDI-Public: 10888277667556
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other