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

Catalog Number	309572
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 3ml ll w/ndl 22x1 rb had a syringe needle connectivity issue.The following information was provided by the initial reporter: material#: 309572, lot#: 1169514.Rcc received a complaint via email.A syringe defect was brought to my attention yesterday afternoon: xxx was to be injected with medication on (b)(6) 2025.The nurse injected the needle into right upper arm and as medication was pushed through the syringe, the entire syringe came apart from the needle.The medication shot out from the syringe and splashed staff and the resident.No one was injured/harmed during this incident.Sample is not available, as it needed to be disposed of properly.Pictures of package wrapper and defective syringe attached for reference.Product name/catalog number- bd plastipak 3ml syringe, luer-lok tip with precision glide needle, 22g x 1¿, #309572, (b)(4), lot#: 1169514, expiration date: 5/31/2026.
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).Follow up it was reported that the syringe became completely detached from the needle.To support the investigation, two photographs of 3ml luer-lok syringes from lot 1169514 were submitted for evaluation by the quality team.One image displays the top web side of the packaging, including all relevant product information.The second image shows a single loose syringe with a needle attached.The needle appears to be positioned at an angle indicative of cross-threading.This condition is non-conforming per product specifications and is attributed to the assembly process.A device history record (dhr) review was conducted for material number 309572, lot 1169514.The review confirmed that all visual inspections were performed in accordance with established requirements, and no quality notifications were recorded related to the reported issue.The lot was inspected and accepted based on the applicable inspection control plan, approved for shipment, and deemed compliant with product specification requirements.To date, no other similar incidents have been reported for this lot.

• Brand Name: BD PLASTIPAK 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: 23015623
• Report Number: 1213809-2025-00587
• Device Sequence Number: 9547142
• Product Code: FMF
• UDI-Device Identifier: 00382903095728
• UDI-Public: (01)00382903095728(17)260531(10)1169514
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/10/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 309572
• Device Lot Number: 1169514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown