MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. SYRINGE, STERILE 60ML; SYRINGE, PISTON

Lot Number CLNA06-03

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

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

Event Type  malfunction  

Event Description

New sterile syringe opened and appeared to have hair/thread inside the barrel.Mckesson 60ml syringe, lot clna06-03, exp 6/17/2024.

• Brand Name: SYRINGE, STERILE 60ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 9954 mayland drive ; richmond VA 23233
• MDR Report Key: 12598336
• MDR Text Key: 276145411
• Report Number: MW5104479
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: CLNA06-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1