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

Model Number	305853
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 8 bd¿ oral dispensing syringe was discovered to be without label markers.The following information was provided by the initial reporter: 3mls oral syringe has no label markers on the syringe.At least 8 from the batch has no labeling.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval: yes; d.10.Returned to manufacturer on: 06-sep-2022.H.6.Investigation summary: one sample and four photos were provided to our quality team for investigation.Through visual inspection, it was observed that the barrel is blank and missing all its scale markings.Potential root cause for the missing print defect is associated with the printer process.These conditions are occurring below their expected frequency so no corrective action is required at this time.A device history record review was completed for provided lot number 9177777.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
It was reported that 8 bd¿ oral dispensing syringe was discovered to be without label markers.The following information was provided by the initial reporter: 3mls oral syringe has no label markers on the syringe.At least 8 from the batch has no labeling.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15250121
• Report Number: 1213809-2022-00509
• Device Sequence Number: 12359712
• Product Code: KNT
• UDI-Device Identifier: 30382903058533
• UDI-Public: 30382903058533
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 305853
• Device Catalogue Number: 305853
• Device Lot Number: 9177777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• 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