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

Catalog Number DYNSCA22100

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/02/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the nurse placed an iv before a procedure and when she went to retract the needle to attach the tubing the needle would not retract.The nurse removed the entire catheter and had to re-stick the patient with a new catheter.No additional information is available.Due to the reported incident and 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

It was reported that the nurse placed an iv before a procedure and when she went to retract the needle to attach the tubing the needle would not retract.The nurse removed the entire catheter and had to re-stick the patient with a new catheter.

• Type of Device: CATHETER, IV, SURESITE AUTO, 22G X 1.00"
• 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: 15272579
• MDR Text Key: 298380690
• Report Number: 1417592-2022-00146
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2022

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 Operator: Health Professional
• Device Catalogue Number: DYNSCA22100
• Device Lot Number: 27822020001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/22/2022
• 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): Required Intervention