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

Catalog Number	309575
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
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#:309575.Batch#: 3331068.It was reported that the bd luer-lok had a scale marking issue.The following information was provided by the initial reporter: "a facility administrator reported to xxxx that a bd 3ml luer-lok syringe 21gx1in had no milliliter markings." verbatim: rcc received a complaint via email.Email(s) attached.Complaint#: (b)(4).Product: bd 3ml luer-lok syringe 21gx1in.Product #: 309575.Lot#: 3331068.Complaint: a facility administrator reported to xxxxx that a bd 3ml luer-lok syringe 21gx1in had no milliliter markings.Dear qa department: the purpose of this letter is to notify you, the manufacturer that xxxx.Na, distributor of your bd 3ml luer-lok syringe 21gx1in, received the above complaint against this product.
Event or Problem Description
Material#:309575, batch#: 3331068.It was reported by the customer that the a facility administrator reported to xxxx that a bd 3ml luer-lok syringe 21gx1in had no milliliter markings.Verbatim: rcc received a complaint via email.Email(s) attached.Complaint#: (b)(4).Product: bd 3ml luer-lok syringe 21gx1in.Product #: 309575.Lot#: 3331068.Complaint: a facility administrator reported to xxxxx that a bd 3ml luer-lok syringe 21gx1in had no milliliter markings.Dear qa department: the purpose of this letter is to notify you, the manufacturer that xxxx.Na, distributor of your bd 3ml luer-lok syringe 21gx1in, received the above complaint against this product.Comments on 05/06/2024.All available information has been provided, regulatory reporting is the responsibility of the manufacturer.
Additional Manufacturer Narrative
Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.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: 19495350
• Report Number: 1213809-2024-00356
• Device Sequence Number: 8611772
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 06/17/2024

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: 309575
• Device Lot Number: 3331068
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/09/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown