MAUDE Adverse Event Report: MCKESSON BRAND CLAVE NEUTRAL CONNECTOR; SET, I.V. FLUID TRANSFER

Model Number MS980

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2024

Event Type  Injury  

Event Description

This morning the nurse called me in because she noticed (b)(6) clave cap was leaking when she flushed it.I changed her cap immediately and examined it and it looks like the blue top leaks between the top and bottom clear housing.The blue top is also collecting fluid when it should be going straight through the center and not filling at all.Clave cap was defective and fluids were leaking out which risks line infection/sepsis.

• Brand Name: CLAVE NEUTRAL CONNECTOR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): MCKESSON BRAND
• MDR Report Key: 19128037
• MDR Text Key: 340520605
• Report Number: MW5153936
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/13/2024

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
• Device Operator: Other
• Device Model Number: MS980
• Device Lot Number: 13650222
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Patient Sequence Number: 1
• Treatment: CURLIN IV INFUSION PUMPS.; GENOTROPIN.; IRON.; METRONIDAZOLE.; MULTIVITAMIN.; OMEGAVEN.; SULFASALAZINE.; TOTAL PARENTERAL NUTRITION.; VIT D.
• Patient Outcome(s): Life Threatening
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White