MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB; SYRINGE, ANTISTICK

Catalog Number	305270
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe integra 3ml w/ndl 25x1 rb leaked.The following information was provided by the initial reporter: verbatim: we set it out for pickup last week.There have not been any pickups.Also, we had another needle today malfunction.I draw up the vaccine but did not administer it.As i mentioned before, i thought it was because the machines were not tightening the needle to the syringe properly.That is not the case.This needle was screwed in properly, but it still leaked vaccine as i was trying to get the air bubbles out.Do you want me to add the new syringe to the shipment? i can label each so there is no confusion.
Additional Manufacturer Narrative
One sample was provided to our quality team for investigation.The sample was tested for leakage and found to have no defects observed.The condition observed is acceptable per product specification.The reported defect was not identified in the samples received, so no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 0293610.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB
• 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: 21032724
• Report Number: 1213809-2024-01000
• Device Sequence Number: 9155531
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708(11)210223(17)260228(10)1054572
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2025

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: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 305270
• Device Lot Number: 0293610
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 02/16/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown