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

Catalog Number	309695
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the bd syringe control 10ml ll had a sterility issue.The following information was provided by the initial reporter: material#: 309695.Batch#: 5177721.Verbatim: rcc received a complaint via email.We have a product concern for 309695 10ml control syringe, lot# 5177721.Packaging is coming apart at the seam.Sterility is compromised.Additional info received on 31-0ct: this happened on (b)(6) 2025.I do not have an image of the product coming apart at the seam but i do have a sample.We have had several occurrences of this nature with this syringe.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Pr (b)(6) - supplemental mdr - sterility questioned.One sample was provided to the quality team for investigation.The sample included all required product information but had a 2-inch open seal with grid on the long side, compromising the sterility of the syringe.This condition does not meet product specifications.The likely root cause of the unsealed package defect is related to the packaging process.Furthermore, a device history record (dhr) review was completed for the provided lot number 5177721.The review showed no rejected inspections or quality issues during production that could have contributed to the reported defect.Complaints for this device and condition will continue to be tracked and trended.Data will be included in monthly trend reports and reviewed regularly by the business team to identify emerging trends.

• Brand Name: 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: 23581797
• Report Number: 1213809-2025-00724
• Device Sequence Number: 9378041
• Product Code: FMF
• UDI-Device Identifier: 00382903096954
• UDI-Public: (01)00382903096954(17)300531(10)5177721
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 309695
• Device Lot Number: 5177721
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown