MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC 20G X 1IN PROTECT IV PLUS SAFETY CATHETER-RADIOPAQUE JELCO; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	3067
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The angiocath hub with tubing was inserted in the antecubital vein of the patient.The area where the hub and tubing meet had an event where the tubing broke and was retained in the patient requiring removal of a foreign object procedure.The tubing was removed successful by the physician with no permanent harm to the patient.The attached pictures are of a new catheter and packaging.The patient's catheter and retrieved tubing has been sequestered per our policy.

• Brand Name: 20G X 1IN PROTECT IV PLUS SAFETY CATHETER-RADIOPAQUE JELCO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC
• MDR Report Key: 18788309
• Report Number: MW5152007
• Device Sequence Number: 7294804
• Product Code: FOZ
• UDI-Device Identifier: 10351688071217
• UDI-Public: 10351688071217
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/21/2024

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: 3067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2024
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Hispanic
• Patient Race: White