MAUDE Adverse Event Report: BD ORAL DISPENSING SYRINGE; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number	305209
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Bd oral dispensing syringes 10ml amber with tip cap lot 0272366 has both 5ml and 10ml syringes in some of the packaging and all 5ml in other packages.Fda safety report id# (b)(4).

• Brand Name: ORAL DISPENSING SYRINGE
• Common Device Name: CONTAINER, LIQUID MEDICATION, GRADUATED
• Manufacturer (Section D): BD; franklin lakes NJ 07417
• MDR Report Key: 14021346
• Report Number: MW5108774
• Device Sequence Number: 17364644
• Product Code: KYW
• UDI-Device Identifier: 30382903052098
• UDI-Public: (01)30382903052098
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 305209
• Device Lot Number: 0272366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown