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
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: 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.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 27 boxes at (b)(6) and 45 boxes at (b)(6).
Additional Manufacturer Narrative
(b)(4).Follow up no sample or photo was provided for investigation.Based on previous findings, the incorrect top web labeling is likely due to a packaging process issue.A corrective and preventive action (capa) has been initiated to address this issue.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.

• 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: 22948625
• Report Number: 1213809-2025-00572
• Device Sequence Number: 9893905
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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