MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE; PISTON SYRINGE

Model Number	305283
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 integra¿ syringe safety mechanism failed to retract the needle.The following information was provided by the initial reporter: "there was a malfunction with the needle and it failed to retract.No harm to patient due to malfunction.Due to the nature of the malfunction of the syringe and needle it appeared that approximately 0.1 ml to 0.2 ml of lai failed to be administered.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/28/2021.H.6.Investigation: one loose 3ml integra syringe (b)(6) and a strip of top web were received.The sample was visually evaluated.The syringe was activated and the spring was separate from the syringe assembly.Physical non-activated samples sealed in blisterpaks are required to perform a more thorough evaluation and perform functional testing to confirm the defect.Since the sample received did not confirm the reported condition a potential root cause could not be defined, and corrective actions are not necessary.Physical unused and sealed samples from the same batch are required for a more in-depth evaluation and potential root cause determination.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd integra¿ syringe safety mechanism failed to retract the needle.The following information was provided by the initial reporter: "there was a malfunction with the needle and it failed to retract.No harm to patient due to malfunction.Due to the nature of the malfunction of the syringe and needle it appeared that approximately 0.1 ml to 0.2 ml of lai failed to be administered.".

• Brand Name: BD INTEGRA¿ SYRINGE
• Common Device Name: PISTON 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12556527
• Report Number: 1213809-2021-00684
• Device Sequence Number: 19831047
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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 Expiration Date: 06/30/2023
• Device Model Number: 305283
• Device Catalogue Number: 305283
• Device Lot Number: 8184681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2018
• 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