MAUDE Adverse Event Report: COVIDIEN MONOJECT 12 ML PHARMACY TRAY; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 2021010564

Device Problems Component Missing (2306); Structural Problem (2506)

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

Event Date 03/06/2021

Event Type  malfunction  

Event Description

Patient had a double lumen picc placed and received tpa in both ports at 2200 and 2300.Upon removal of syringe it was noted that the plastic nipple that inserts into picc line was noted to be missing.Upon examining port, it was noted that the plastic nipple was in the port.Bedside nurse aware and picc line was removed.Md was notified.Fda safety report id# (b)(4).

• Brand Name: MONOJECT 12 ML PHARMACY TRAY
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11494861
• MDR Text Key: 240373062
• Report Number: MW5100001
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 03/09/2021

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: Health Professional
• Device Lot Number: 2021010564
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 41