MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL 200 S/C; PISTON SYRINGE

Catalog Number	309657
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #:309657; batch#:4116045.It was reported that the bd syringe 3ml ll 200 s/c leaked.The following information was provided by the initial reporter: while administering depo injection, medication began to leak from hub where needle was inserted into syringe, even though it was screwed in tightly and correctly.305902 also attached lot # 4095458.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(6): supplemental mdr - leakage.One sample was provided to our quality team for investigation.The sample was tested for leakage test, and no leakage was observed.The condition observed is acceptable per product specification.Furthermore, a device history record review was completed for provided lot number: 4116045.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD SYRINGE 3ML LL 200 S/C
• 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: 20444596
• Report Number: 1213809-2024-00708
• Device Sequence Number: 7990740
• Product Code: FMF
• UDI-Device Identifier: 30382903059028
• UDI-Public: (01)30382903059028(11)240404(17)290331(10)4095458
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/07/2025

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: 309657
• Device Lot Number: 4116045
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown