MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL DISPENSING SYRINGE; LIQUID MEDICATION DISPENSER

Catalog Number	305217
Medical Device Problem Codes	Defective Component (2292); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd¿ oral dispensing syringe had difficult plunger movement while trying to push out medication.The following information was provided by the initial reporter: "can draw - but is tremendous force to get any medication out.Every single one in the box - used to always be a few but so far this whole box is the same way.Got her box in august 29th but she has been reusing other ones from pervious orders since these do not see to be working.".
Additional Manufacturer Narrative
Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We appreciate you taking the time to bring this observation to our attention.We regret any inconveniences this incident may have caused you and your facility.See narrative below.
Event or Problem Description
No additional information was provided.

• Brand Name: BD¿ ORAL DISPENSING SYRINGE
• Common Device Name: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17848897
• Report Number: 1213809-2023-01087
• Device Sequence Number: 7313444
• Product Code: KYW
• UDI-Device Identifier: 50382903052177
• UDI-Public: (01)50382903052177
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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: Lay User/Patient
• Device Catalogue Number: 305217
• Device Lot Number: 3191197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown