MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE; ANTISTICK SYRINGE

Model Number	305274
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bd intregra¿ syringe with detachable needle retracted prematurely.This event occurred 3 times.The following information was provided by the initial reporter: we have recently had three needles that have retracted early meaning the patient has not received their full dose of medication and has had to have a second injection.
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 intregra¿ syringe with detachable needle retracted prematurely.This event occurred 3 times.The following information was provided by the initial reporter: we have recently had three needles that have retracted early meaning the patient has not received their full dose of medication and has had to have a second injection.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-mar-070.Investigation summary : three 3ml integra syringes (material 305274) were received and evaluated.The needles have been retracted, the spring is between the cutter and the tip of the syringe inside the barrel and the retracted needle is inside the inner plunger rod.The reported defect was not identified in the samples received.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A sealed physical sample in a package is required for a more thorough 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.

• Brand Name: BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• 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: 13417532
• Report Number: 1213809-2022-00032
• Device Sequence Number: 3872034
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 305274
• Device Catalogue Number: 305274
• Device Lot Number: 0259747
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown