MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309632
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
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
Material#: 309632, batch number#: 4066411.It was reported that the bd luer-lok had a syringe needle connectivity issue.The following information was provided by the initial reporter: rcc received a complaint via email.The syringe needle is found to not be fully twisted into the secured position in the syringe cap.The needle requires twisting with the cap to securely attach it to the barrel.Even with twisting, the needles may detach.The cap sometimes does not easily lock, even after tapping it closed.Also, due to the needle not being fully inserted, the shield that caps the needle of the 5ml bd syringe (lot: 4066411) was coming off too easily.Pharmacist was placing the capped syringe facing down into a dose calibrator to measure dose activity.Upon lifting the syringe out of the dose calibrator, the cap remained stuck inside the dose calibrator, exposing the needle of the syringe.A similar occurrence was not previously reported for this lot number.However, the pharmacist had this happen 3 times in a row.The failure rate was 3 out of 18.Product#: 309632, lot#: 4066411.Additional information provided: 1.It was mentioned "the syringe needle is found to not be fully twisted into the secured position in the syringe cap.The needle requires twisting with the cap to securely attach it to the barrel.Even with twisting, the needles may detach.The cap sometimes does not easily lock, even after tapping it closed.Also, due to the needle not being fully inserted, the shield that caps the needle of the 5ml bd syringe (lot: 4066411) was coming off too easily" could you please conform that mentioned syringe cap was luer cap or needle cap? it was both.2.If the failure was connection issue, could you please conform failure happened between cap & needle or syringe & needle? the primary failure happened between the needle and the syringe.This also affected the cap and made it easy for the cap to fall off.3.If there are different failure occurred, please conform number of occurrence for each failure.There have been at least 7 occurrences.There have been more individual occurrences that have not escalated to a scar or customer complaint.
Additional Manufacturer Narrative
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.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.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 LUER-LOK
• Common Device Name: PISTON 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21414744
• Report Number: 1213809-2025-00112
• Device Sequence Number: 21168498
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: (01)30382903096320(11)240306(17)290228(10)4066411
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 03/04/2025

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: 309632
• Device Lot Number: 4066411
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown