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

Catalog Number	305274
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, 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.Dhr review results: released quantity was 164,400.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 1029961 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.
Event or Problem Description
It was reported that the needle failed to retract on the bd intregra¿ syringe with detachable needle.The following information was provided by the initial reporter: "the plunger was pushed to engage needle to retract but instead of retracting, the entire needle and green hub came off.".

• 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: 15035019
• Report Number: 1213809-2022-00406
• Device Sequence Number: 20118663
• Product Code: MEG
• UDI-Device Identifier: 00382903052745
• UDI-Public: 00382903052745
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: 01/31/2026
• Device Catalogue Number: 305274
• Device Lot Number: 1029961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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