MAUDE Adverse Event Report: BD ORAL AMBER SYRINGE; DISPENSER, LIQUID MEDICATION

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  No Answer Provided  

Event Description

Bd 1 ml oral amber syringes lack leading zero on measurement markings.Medication administered to or used by the patient: no.Patient counseling provided: unknown.Ismp, (b)(6), access number: (b)(4).

• Brand Name: ORAL AMBER SYRINGE
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BD
• MDR Report Key: 10294897
• MDR Text Key: 199660082
• Report Number: MW5095575
• Device Sequence Number: 1
• Product Code: KYX
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1