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	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material #305060.Lot #4277738.It was reported that the bd syringe 3ml ll w/ndl 18x1-1/2 blunt fill was coring.The following information was provided by the initial reporter: verbatim: customer reports blunt fill needles are causing coring when drawing up solumedrol.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4)- supplemental mdr - coring needle.It was reported blunt fill needles are causing coring.As a physical sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, four photos were received for evaluation by our quality team.Two photos show a needle inserted in a stopper vial.The other two photos show a needle without the plastic shield assembled a syringe next to a packaging blister top web.No defects or imperfections were observed.A device history record review was completed for provided material number 305060, lot 4277778.The review revealed all visual inspections were performed per requirements with no quality notifications related to the defect reported.The lot was inspected and accepted based on our inspection control plan and approved for shipment.Additional device histories were reviewed for each batch of needles used in the manufacturing of this batch.There was no documentation for this type of condition during the entire production run of these batches.Based on the investigation with the photo sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
No additional information was provided.

• 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: 21241156
• Report Number: 1213809-2025-00038
• Device Sequence Number: 11672646
• Product Code: FMF
• UDI-Device Identifier: 30382903050605
• UDI-Public: (01)30382903050605(11)241003(17)290930(10)4277738
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/17/2025

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: 305060
• Device Lot Number: 4277738
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown