MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/INTERLINK VAC; PISTON SYRINGE

Catalog Number	303401
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
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
Materials#: 303401, batch#: 3348875.It was reported that the bd syringe 3ml ll w/interlink vac had a scale marking issue.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.3ml bd luer-lok tip with vial access cannula syringe without ml markings.Product#: 303401.Lot#: 3348875.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Four photos of a 3ml luer-lok syringe with needle attached were received by bd.A quality engineer was able to examine the photos from batch 3348875 regarding item 303401.Two of the photos show the sealed package with one being a close-up image showing all applicable product information.One of the photos shows a sealed package with the syringe included with no defects observed, and one photo shows one loose syringe with all of the scale markings missing.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 3348875 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 SYRINGE 3ML LL W/INTERLINK VAC
• 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: 19690950
• Report Number: 1213809-2024-00430
• Device Sequence Number: 7081146
• Product Code: FMI
• UDI-Device Identifier: 00382903034017
• UDI-Public: (01)00382903034017(11)231214(17)281130(10)3348875
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 303401
• Device Lot Number: 3348875
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown