MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3ML SYRINGE; ANTISTICK SYRINGE

Model Number	305269
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd integra 3ml syringe will not draw up medication.The following information was provided by the initial reporter: " integra style syringe will not draw up my medication.".
Additional Manufacturer Narrative
H6: investigation summary: eight sample were provided to our quality team for investigation.Through visual inspection six samples were observed to have a insufficient peel tab.All samples were also observed not to be clogged as evidenced by light clearly passing through each cannula.The expiration date printed on each package and product has been expired since march 31st, 2022.Potential root cause for the insufficient peel tab defect is associated with the packaging process process.Since the defect concerns expired product, corrective actions are not necessary.A potential root cause could not be established for the clogged needle defect as no samples displaying the reported condition were received.
Event or Problem Description
It was reported that the bd integra 3ml syringe will not draw up medication.The following information was provided by the initial reporter: " integra style syringe will not draw up my medication.".

• Brand Name: BD INTEGRA 3ML SYRINGE
• Common Device Name: ANTISTICK SYRINGE
• 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: 14961899
• Report Number: 1213809-2022-00381
• Device Sequence Number: 17514371
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: 30382903052692
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: 03/31/2022
• Device Model Number: 305269
• Device Catalogue Number: 305269
• Device Lot Number: 7082691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2017
• 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