MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYR 10ML LL W/NDL 18X1-1/2 BLUNT FIL; PISTON SYRINGE

Catalog Number	305064
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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
Material# 305064.Batch# 4037749.It was reported that the bd syr 10ml ll w/ndl 18x1-1/2 blunt fil had a syringe needle connectivity issue.The following information was provided by the initial reporter: needle is not screwed on correctly to syringe.
Additional Manufacturer Narrative
It was reported the needle is not screwed on correctly to the syringe.As a sample was not returned a thorough sample evaluation could not be performed.To aid in the investigation, one photo of a 10ml luer lok syringe with a blunt fill needle was received and evaluated by our quality team.The photo shows one loose syringe with the needle attached lying next to a package showing the top web.The defect reported could not be observed or confirmed from the photo provided.A device history record review was completed for provided material number 305604, lot 4037749.The review revealed all visual inspections were performed per requirements with no quality notifications related to the reported defect.Lot 4037749 was inspected and accepted on meeting our inspection control plan, approved for shipment, and is considered in compliance with our product specification requirements.To date, there have been no other similar events reported for this lot.No further action is required at this time.Based on the investigation, the defect reported was not identified.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 SYR 10ML LL W/NDL 18X1-1/2 BLUNT FIL
• 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: 19690819
• Report Number: 1213809-2024-00429
• Device Sequence Number: 8009541
• Product Code: FMF
• UDI-Device Identifier: 30382903050643
• UDI-Public: (01)30382903050643(11)240206(17)290131(10)4037749
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/20/2024

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: Health Professional
• Device Catalogue Number: 305064
• Device Lot Number: 4037749
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown