MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER, IV, SURESITE AUTO, 22G X 1.00"

Catalog Number DYNSCA22100Z

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported by a nurse that the iv catheters were difficult to thread resulting in multiple iv catheter insertion attempts with multiple patients.According to the nurse, although she does not recall the specifics of the situation or the total number of patient's impacted by the issue she does recall that she has used the product many times without incident until the day the incident occurred.The day of the incident the nurse reported that she attempt to insert iv's into children in the facility and she was unable to thread the catheter as usual.The nurse reported that she made multiple iv attempts instead of the usual 1 attempt before successful insertion.The nurse stated there were no serious injuries, she applied pressure dressings over the areas of that patients with the unsuccessful iv attempts with no additional intervention required.No additional information is available.Due to the reported incident and in an abundance of caution, this is an mdr reportable event.If additional information becomes available this report will be reopened and reevaluated.

Event Description

It was reported that the iv catheters would not properly thread with an unknown number of patients which required additional iv sticks.

• Type of Device: CATHETER, IV, SURESITE AUTO, 22G X 1.00"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, il ; 6434960
• MDR Report Key: 9953093
• MDR Text Key: 190762572
• Report Number: 1417592-2020-00028
• Device Sequence Number: 1
• Product Code: FOZ
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNSCA22100Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention