MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS INTERLINK LUER-LOK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303393
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 10ml ll w/twinpak device label content was incorrect.The following information was provided by the initial reporter: material#: 303393.Batch#: 5065846.Verbatim: rcc received a complaint via email.Chc complaint reference #: (b)(4).Hospital complaint reference #: (b)(4).Cat# of product being complained: bd303393 description of product: syringe 10cc w/cannula st intlink 100ea/bx 4bx/ca.Lot or s/n: (b)(6) complaint category: labelling issue.Reportable: no.Incident date: (b)(6) 2025.Hospital complaint reference #: (b)(4) details of complaint (reported issue): "xx came in boxes that say they are 10ml syringes, the packaging of the syringes says they are 5ml syringes, and the syringe inside the packaging is a 10ml".Please note: incident date & quantity of product affected is unknown.Complaint noticed: prior to use.Problem frequency: a few times.Customer exposure: patient injury: no.Has health canada been informed? unknown.Qty affected: 1 bx.Samples available? yes.Is customer requesting an rga? no.Return qty: qty samples: 1 bx.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - label content incorrect.One thousand twenty-three samples of 10ml twinpak syringes (material 303393) from batch 5065846 were evaluated.All samples arrived in sealed packages without box cartons.Among them, three packages contained 3ml syringes, which are not relevant to the reported complaint, and one package contained a conforming 10ml syringe with no defects.The remaining one thousand nineteen packages contained 10ml syringes but were incorrectly labeled with 5ml top web packaging.The condition observed is non-conforming per product specification.Potential root cause for the incorrect top web defect is associated with the packaging process.A corrective and preventive action (capa) will be initiated to address the issue and prevent recurrence.Furthermore, a device history record review was completed for provided lot number 5065846.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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.
Event or Problem Description
No additional information was provided.

• Brand Name: INTERLINK LUER-LOK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 22425611
• Report Number: 1213809-2025-00458
• Device Sequence Number: 3164122
• Product Code: FMI
• UDI-Device Identifier: 00382903033935
• UDI-Public: (01)00382903033935(17)300228(10)5065846
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 303393
• Device Lot Number: 5065846
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown