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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Other lot number includes 3234572 and other expiration date includes 2028-07-31.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.H.4.Other lot number device manufacture date is 2023-08-22.
Event or Problem Description
Material # 305269.Lot # 3234572, 3256108.It was reported that the bd syringe integra 3ml ll w/ndl 25x5/8 rb had a syringe needle connectivity issue.The following information was provided by the initial reporter: "recently, while attempting to administer injections using bd item #305269, our end-users have encountered a recurring problem where the needle separates from the syringe during the process.This has been both frustrating and concerning for our staff as it could compromise the safety and effectiveness of the procedure.We would greatly appreciate it if you could look into this matter and provide us with any insights or suggestions on how to address this issue.".
Additional Manufacturer Narrative
Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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 actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We appreciate you taking the time to bring this observation to our attention.
Event or Problem Description
No additional information was provided.

• 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: 19506716
• Report Number: 1213809-2024-00364
• Device Sequence Number: 7498325
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: (01)30382903052692(11)230913(17)280831(10)3256108
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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 Catalogue Number: 305269
• Device Lot Number: 3256108
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown