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

Catalog Number	309659
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 309659.Batch # 3212670.It was reported that the bd luer-lok had leakage at the luer connection.The following information was provided by the initial reporter: "when needing to use on sub out port, syringe does not securely attach to micro clave, resulting in medication leaking and syringe detachment, resulting in a potential for an adverse." verbatim: rcc received a complaint via email.Email(s) attached.When needing to use on sub out port, syringe does not securely attach to micro-clave, resulting in medication leaking and syringe detachment, resulting in a potential for an adverse.Cat# of product being complained: 309659.Description of product: syringe tuberculin l/sl st 1ml disp clr scale 200ea/bx 8bx/ca lot number: 3212670.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 309659, batch # 3212670.It was reported by customer that when needing to use on sub out port, syringe does not securely attach to micro clave, resulting in medication leaking and syringe detachment, resulting in a potential for an adverse.Verbatim: rcc received a complaint via email.Email(s) attached.When needing to use on sub out port, syringe does not securely attach to micro-clave, resulting in medication leaking and syringe detachment, resulting in a potential for an adverse.Cat# of product being complained: 309659.Description of product: syringe tuberculin l/sl st 1ml disp clr scale 200ea/bx 8bx/ca.Lot number: 3212670.
Additional Manufacturer Narrative
Since no samples displaying the reported condition were received, a potential root cause could not be defined, and corrective actions are unnecessary.A physical sample is required for a more thorough evaluation and potential root cause determination.

• Brand Name: BD 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: 19273602
• Report Number: 1213809-2024-00275
• Device Sequence Number: 12615396
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: (01)30382903096597
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: 309659
• Device Lot Number: 3212670
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown