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

Catalog Number	309642
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material: 309642 batch#: 3324733 it was reported that the bd luer-lok had a scale marking issue.The following information was provided by the initial reporter: "bd 10ml luer-lok syringe 21gx1in had no measurement markings." verbatim: rcc received a complaint via email.Email(s) attached fresenius customer complaint (b)(4).Customer: xxxx product: bd 10ml luer-lok syringe 21gx1in vendor part#: 309642 lot number: 3324733 complaint: it was reported to xxxxxx that a bd 10ml luer-lok syringe 21gx1in had no measurement markings.Dear customer complaints: the purpose of this letter is to notify you, the manufacturer, that xxxxx na, distributors of your bd 10ml luer-lok syringe 21gx1in, received the above complaint.Fresenius medical care na requests that your organization address any follow-up investigation directly with the complainant.
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
No additional information was provided.
Additional Manufacturer Narrative
One sample of a 10ml luer-lok syringe with 21x1" needle attached (p/n - 309642) batch 3324733 was received and evaluated.The one sample received in the unsealed package was missing all the scale markings on the barrel.The condition observed is non-conforming per product specification.Potential root cause for the scale markings missing defect is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.A device history record review was completed for provided lot number 3324733 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.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.

• 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: 19217740
• Report Number: 1213809-2024-00264
• Device Sequence Number: 12796717
• Product Code: FMF
• UDI-Device Identifier: 30382903096429
• UDI-Public: (01)30382903096429(11)231120(17)281031(10)3324733
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/06/2024

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 Catalogue Number: 309642
• Device Lot Number: 3324733
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown