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

Catalog Number	309581
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 3ml ll w/ndl 25x1 rb needle pulled out of the hub.The following information was provided by the initial reporter: material #309581.Batch #4137800.Verbatim: rcc received a complaint via email.Contact name: contact number: contact email (if available): item(s): 309581 lot(s): 4137800 date incident occurred: late last year and (b)(6) 2025.Was the patient impacted? yes.If yes, describe: portion of the needle popped off and sprayed medication everywhere, wife was exposed to testosterone and was not able to take the medication.Is a sample available? yes.
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.
Additional Manufacturer Narrative
Pr (b)(4) - supplemental mdr/correction - needle pulled out of hub.Correction: following submission of initial mdr, the customer information was not correctly reported.Section e updated to reflect correct customer address.One sample of a 3ml luer-lok syringe with a 25x1¿ needle (part number 309581, batch 4137800) was received and evaluated.The syringe and needle were received in an unsealed package.Upon inspection, no defects were observed.The needle cannula remained securely attached to the hub, and leak testing confirmed no leakage.The condition observed is acceptable per product specifications.It is recommended to hand-tighten the needle onto the syringe prior to use to ensure secure attachment.Furthermore, a device history record review was completed for provided lot number 4137800.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.
Event or Problem Description
No additional information was provided.

• Brand Name: 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: 22066970
• Report Number: 1213809-2025-00342
• Device Sequence Number: 15839800
• Product Code: FMF
• UDI-Device Identifier: 30382903095811
• UDI-Public: (01)30382903095811(11)240516(17)290430(10)4137800
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: Lay User/Patient
• Device Catalogue Number: 309581
• Device Lot Number: 4137800
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown