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

Model Number 305269

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

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 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.".

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 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
• Type of Device: 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
• MDR Text Key: 296879568
• Report Number: 1213809-2022-00381
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: 30382903052692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1