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

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: "3ml bd luer-lok tip with vial access cannula syringe without ml markings.Can¿t measure an amount of medication inside without markings" verbatim: rcc received a complaint via email.Email(s) attached.We received a report from our saint raphael¿s campus clinicians concerning an event they have experienced while using a 3ml bd luer-lok tip with vial access cannula syringe (bd303401).The lot number is 3348875.The event date is (b)(6) 2024.No harm to the patient has been reported.The sample is sequestered to conduct an analysis to determine the root cause of the failure.Please let me know the next step.We are willing to send the sample.Please have an rma and mailer label sent to my attention.The complaint is described: s; 3ml bd luer-lok tip with vial access cannula syringe without ml markings.B: can¿t measure an amount of medication inside without markings.A: lot # 3348875.R: item sequestered.
Additional Manufacturer Narrative
(b)(4).- supplemental mdr - scale marking issue.One sample from batch 3348875 was provided to our quality team for investigation.Through visual inspection, it was observed that the syringe 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.This defect is occurring below an expected rate, so no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 3348875.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 3ML LL W/INTERLINK VAC
• Common Device Name: NEEDLE
• 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: 19326092
• Report Number: 1213809-2024-00290
• Device Sequence Number: 2608560
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: Other
• Device Catalogue Number: 303401
• Device Lot Number: 3348875
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 11/15/2024
• 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