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

Catalog Number	305270
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 305270; batch # 3355122.It was reported that the bd integra needle pulled out of the hub.The following information was provided by the initial reporter: rcc received a complaint via phone.Customer left voicemail and advised: she has experienced issues with the bd integra syringe 3ml 25g x1 , 1st incident: the plunger is not holding medicine in front of it and the medication is ending up behind the plunger and she is not getting all the medication.Has happened a couple of times, the most recent one occurred on (b)(6) 2024, lot 3355122, ref 305270.Medication is drawn from vial, 2nd incident: the other day, used another needle, when the plunger was pushed to get air out, the plunger reassessed in to the back of the syringe and the needle went flying across the bathroom.In addition, the needle does not retract as stated.305270 lot 3355122.Date of event 10/09/2024.No pt harm or injury.Sample.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Two samples were provided to our quality team for investigation.One sample had the needle cannula retracted into the syringe and it was verified that the needle cannula was inside the inner plunger rod as designed.The syringe with the needle retracted upon arrival cannot be leak tested as the design of the retraction compromises the stopper.The next syringe was tested for leakage and found to be acceptable, and upon completion of testing when the plunger rod was fully depressed the needle cannula retracted as designed.The conditions observed are acceptable per product specification.The reported defects were not identified in the samples received.Therefore, no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 3355122.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INTEGRA
• Common Device Name: SYRINGE, ANTISTICK
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20630183
• Report Number: 1213809-2024-00801
• Device Sequence Number: 7929853
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708(11)231221(17)281130(10)3355122
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: Lay User/Patient
• Device Catalogue Number: 305270
• Device Lot Number: 3355122
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown