MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. SYRINGE 60ML; SYRINGE, IRRIGATING (NON DENTAL)

Lot Number CLNJ06-01

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2021

Event Type  No Answer Provided  

Event Description

Mckesson 60ml syringe in sealed package was used in clean room and noted to have a contaminant inside the barrel (navy colored thread).

• Brand Name: SYRINGE 60ML
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 9954 mayland drive; richmond VA 23233
• MDR Report Key: 12561757
• MDR Text Key: 274656628
• Report Number: MW5104306
• Device Sequence Number: 1
• Product Code: KYZ
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/03/2021
• Device Lot Number: CLNJ06-01
• 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