MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; CANNULA, SURGICAL, GENERAL PLASTIC SURGERY

Model Number 8881540111

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2019

Event Type  malfunction  

Event Description

First occurrence noted, anesthesia resident attached a blunt needle to a syringe with prefilled saline flush.The resident noticed there what appeared to be mold on the blunt needle.Did not reach patient and blunt needle was confiscated.Second occurrence noted a month and a half later, certified registered nurse anesthetist noted visible black particles in monojet needleless blunt cannula.Noted when medication was drawn up.Did not give to patient.Lot number 923832.Took a photo of packaging.

• Brand Name: MONOJECT
• Type of Device: CANNULA, SURGICAL, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9174158
• MDR Text Key: 161810368
• Report Number: 9174158
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2019

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 Model Number: 8881540111
• Device Catalogue Number: 8881540111
• Device Lot Number: 923832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Weight: 87