MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB; SYRINGE, ANTISTICK

Catalog Number	305269
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305269, batch number#: 3314055.It was reported that the bd syringe integra 3ml ll w/ndl 25x5/8 rb had leakage past the stopper.The following information was provided by the initial reporter: it was reported by customer that many sites have reported two main issues with this product: 1-syringe causing liquid to leak out beyond the plunger 2-the needle is not retracting and they are left in the patient after administration requiring clinical staff to pull them out.Rcc received a complaint via email.Email(s) attached.Many sites have reported two main issues with this product: 1-syringe causing liquid to leak out beyond the plunger 2-the needle is not retracting and they are left in the patient after administration requiring clinical staff to pull them out.Our organization has received numerous reports and this has impacted patient care and quality of treatment being provided.I also looked in maude and found 25 reports regarding this product: 25 records meeting your search criteria returned- model number: 305269 manufacturers: becton dickinson report date from: 07/01/2018 report date to: 07/31/2024 product#: 305269 lot#: 3314055.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.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.

• Brand Name: BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 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: 20977145
• Report Number: 1213809-2024-00970
• Device Sequence Number: 11792787
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: (01)30382903052692(11)231110(17)281031(10)3314055
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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 Catalogue Number: 305269
• Device Lot Number: 3314055
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown