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

Catalog Number	309579
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
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
It was reported that the bd luer-lok has a scale marking issue.The following information was provided by the initial reporter: customer states that they have roughly 13 syringes without any markings.The customer does have unused samples they can return for investigation if needed.Customer would like replacements.Product number: 309579; lot number: 1022131.Additional information provided on 03/06/2024: 1.Date this was discovered and product isolated: either 3/2/24 or 3/3/24 (over the weekend).2.No direct impact to patient as product was quickly isolated and not used.3.No adverse event or serious injury reported.4.For address, please use the following: (b)(6).
Additional Manufacturer Narrative
Thirteen samples of 3ml luer-lok syringes with 20x1-1/2" needles attached lot 1022131 were received and evaluated.Twelve of the samples received were in sealed packages and one was loose with no needle attached.All samples were missing all scale markings.The condition observed is non-conforming per product specification.Potential root cause for the missing print defect is associated with the marking process.A device history record review was completed for provided lot number 1022131 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
Materials #: 309579 batch #: 1022131.It was reported by the customer that they have roughly 13 syringes without any markings.Verbatim: rcc received a complaint via phone.Pir attached.Customer states that they have roughly 13 syringes without any markings.The customer does have unused samples they can return for investigation if needed.Customer would like replacements.Product number: 309579; lot number: 1022131.

• 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: 18965400
• Report Number: 1213809-2024-00178
• Device Sequence Number: 7906438
• Product Code: FMF
• UDI-Device Identifier: 30382903095798
• UDI-Public: (01)30382903095798
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/05/2024

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: Other
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 309579
• Device Lot Number: 1022131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown