MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; KIT,IV START,CHLORAPREP FREPP,TEGADERM

Model Number	DYND74278
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer contact, the tape that is being used to "reinforce catheters" is "not sticking".It was reported that the tape is causing "slipping out of the vein" when medications are infusing "causing an infiltration", the tape is being used for peripheral iv sites in the upper extremity, according to the customer.It was reported that an additional iv site was required due to the reported event.No additional details were provided by the customer.A sample was returned but a root cause could not be determined at this time.It has been determined that the reported event caused or contributed to serious injury therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Adhesive causing ivs to slip and causing infiltration.

• Brand Name: MEDLINE
• Common Device Name: KIT,IV START,CHLORAPREP FREPP,TEGADERM
• 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: 16435962
• Report Number: 1417592-2023-00074
• Device Sequence Number: 19620778
• Product Code: LRS
• UDI-Device Identifier: 10080196993024
• UDI-Public: 10080196993024
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/24/2023

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 Model Number: DYND74278
• Device Catalogue Number: DYND74278
• Device Lot Number: 2022112290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (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