MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROTECTIV SAFETY IV CATHETER-RADIOPAQUE JELCO 18G JELCO IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number GTIN 10351688071095

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/24/2022

Event Type  Injury  

Event Description

Upon the discontinuation of an 18gx1 1/4" smiths medical jelco protectiv safety iv catheter, the catheter approximately 1/16" of the catheter remained attached to the hub while the remaining 1 3/16" of the catheter remained in the soft tissue of the medial aspect of the right elbow.Fda safety report id #:(b)(4).

• Brand Name: PROTECTIV SAFETY IV CATHETER-RADIOPAQUE JELCO 18G JELCO IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; southington CT 06489
• MDR Report Key: 13541845
• MDR Text Key: 285713209
• Report Number: MW5107458
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2023
• Device Model Number: GTIN 10351688071095
• Device Catalogue Number: 3055
• Device Lot Number: 4024851
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American