MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL; PISTON SYRINGE

Catalog Number	305060
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and il was used.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material#: 305060 batch number#: 4250612 it was reported that the syringe 3ml ll w/ndl 18x1-1/2 blunt fill had foreign matter.The following information was provided by the initial reporter: verbatim#: rcc received a complaint via email.Email(s) attached please see the product complaint below and pictures attached.This has been reported to our internal team under case.(b)(4).(b)(4) 1ea lot number 4250612 customer comments: the staff in xx pulled item 305060 from the bins and notified us that it was dirty inside the unopened packaging.Cah po ordered on is unknown.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
One sample and two photos were provided to our quality team for investigation.A visual inspection was performed and embedded foreign matter was observed in the barrel.The condition observed is non-conforming per product specification.The potential root cause for the embedded foreign matter defect is associated with the molding process.These conditions are occurring below their expected frequency so, no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 4250612.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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.

• Brand Name: BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL
• 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: 20860366
• Report Number: 1213809-2024-00925
• Device Sequence Number: 3864482
• Product Code: FMF
• UDI-Device Identifier: 30382903050605
• UDI-Public: (01)30382903050605(11)240906(17)290831(10)4250612
• 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): 02/13/2025

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: Other
• Device Catalogue Number: 305060
• Device Lot Number: 4250612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown