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

Device Problem Device Markings/Labelling Problem (2911)

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

Event Description

No known medication errors have occurred locally related to the issue below.Due to shortages and inventory fluctuations, mckesson 60 ml syringes have been purchased for sterile compounding.During daily inspection, it was noted that these syringes list graduations as "cc" on one side while the other side lists graduations in "oz".Furthermore these syringes do not have "ml" notation printed on the packaging nor the syringe.This is worrisome as no sterile or parenteral medication should be measured/dosed in ounces.This also raises concern that oral solutions potentially dosed in ounces could be administered via iv route since these syringes have luer-lock heads.(b)(6).Submission id: (b)(4).

• Brand Name: MCKESSON SYRINGE 60ML
• Type of Device: SYRINGE, IRRIGATION (NON DENTAL)
• Manufacturer (Section D): MCKESSON MEDICAL SURGICAL, INC.; 6555 state hwy 161; irving TX 75039
• MDR Report Key: 12952583
• MDR Text Key: 281939944
• Report Number: MW5105835
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• 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: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1