MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,IV,SURESITE SLIDE,22G X 1"

Catalog Number	DYNSCS22100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the iv catheters were dull and that an unknown number of patients required additional iv sticks.Reportedly, patients experienced pain and discomfort to the iv insertion sites and that ice packs were applied to these sites.No adverse impact to a patient was reported to the manufacturer.Unused samples were returned to the manufacturer for evaluation.Visual inspection and functional testing were performed.No manufacturing defects were identified and the tested samples were found to have no difficulties during use.The reported product problem/issue was unable to be confirmed.A root cause was not determined.Due to the reported need for additional iv sticks, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the iv catheters were dull and that an unknown number of patients required additional iv sticks.

• Common Device Name: CATHETER,IV,SURESITE SLIDE,22G X 1"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8982623
• Report Number: 1417592-2019-00143
• Device Sequence Number: 365851
• Product Code: FOZ
• UDI-Device Identifier: 10888277667549
• UDI-Public: 10888277667549
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNSCS22100
• Device Lot Number: 27818110002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention