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

Model Number	DYNDV1352B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2022 'the tape in the iv start kit is not adhering to the patient's skin causing the iv to dislodge from the patient, requiring and additional iv start'.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 'the tape in the iv start kit is not adhering to the patient's skin causing the iv to dislodge from the patient, requiring and additional iv start'.Per the facility the tape was not exposed to any fluids, and nothing was used on the patient's skin prior to the iv start.Per the facility the only tape that was used was the tape provided in the kit.The device is not available to be returned for evaluation.No additional information is available at this time.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.

• Brand Name: MEDLINE
• Common Device Name: IV START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16095736
• Report Number: 1417592-2023-00015
• Device Sequence Number: 12401832
• Product Code: LRS
• UDI-Device Identifier: 10884389553640
• UDI-Public: 10884389553640
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/04/2023

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
• Operator of Device: Health Professional
• Device Model Number: DYNDV1352B
• Device Catalogue Number: DYNDV1352B
• Device Lot Number: 2022050890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 01/04/2023
• 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