MAUDE Adverse Event Report: MCKESSON MEDICAL SURGICAL INC. MCKESSON 10CC LUER LOCK TIP SYRINGE; SYRINGE, PISTON

Lot Number CJCA08-02

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

We discovered that the package states 10cc syringe for mckesson's 10cc syringe, but the actual barrel of the syringe has markings to 12ml.This could be a potential for a med error to occur.Manufacturer/labeler poor product design: (i.E.Vial, syringe, bag).Circumstances or events have capacity to cause error.(b)(6).Submission: (b)(4).

• Brand Name: MCKESSON 10CC LUER LOCK TIP SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MCKESSON MEDICAL SURGICAL INC.
• MDR Report Key: 13929020
• MDR Text Key: 288172506
• Report Number: MW5108530
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2022

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 Lot Number: CJCA08-02
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2022
• Patient Sequence Number: 1