MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 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	08/08/2025
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 syringe 10ml ll w/twinpak device label content was incorrect.The following information was provided by the initial reporter: material#: 303393.Batch#: 5065846.Verbatim: xx sticker says 303393 (10cc) on the outside of the box but in-side of the individual each/packaging says 303392 (5cc), but the product in-side the wrapper is actually the 10cc.Additional information provided: the product was discovered on 08/08/2025 at our (b)(6) hospital first, then our (b)(6) hospital after we notified them.We have(b)(4) at (b)(6) and (b)(4) at (b)(6).
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.Four sealed samples of 10ml twinpak syringes (part number 303393) from batch 5065846 were received and evaluated.Each package contained the correct 10ml syringe; however, all were labeled with a 5ml top web, resulting in a labeling discrepancy.This condition is non-conforming per product specifications.The provided images show both sides of the packaging, clearly illustrating the mismatch between the syringe size and the top web label.The root cause appears to be related to the packaging process, and a corrective and preventive action (capa) has been initiated to address the issue.Furthermore, a device history record review was completed for lot number 5065846, which showed no rejected inspections or quality issues during production that could have contributed to the reported defect.

• Brand Name: BD 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: 22877492
• Report Number: 1213809-2025-00568
• Device Sequence Number: 13368169
• Product Code: FMI
• UDI-Device Identifier: 00382903033935
• UDI-Public: (01)00382903033935(17)300228(10)5065846
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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: 08/08/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/07/2025
• 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