MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL W/TWINPAK DEVICE; 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	04/29/2025
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.Hello, we have received a quality complaint on product sold to our customer.Please contact the customer and on any future communication.Injuries or adverse event: no.Item: 303393.Quantity affected: (b)(4).Serial/lot number: n/a.Po: (b)(4).Are any samples available for return? yes.Reported issue: the product in the boxes is different product than what the boxes read.The outside of the boxes say b-d303393 but b-d303392 are the syringes inside.
Additional Manufacturer Narrative
Four hundred samples of 10ml twinpak syringes from material 303393, batch 5065846, were received and evaluated.All samples arrived sealed in four case boxes and were confirmed to contain 10ml syringes.However, the top web labeling on all packages incorrectly indicated 5ml.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.

• Brand Name: BD SYRINGE 10ML LL W/TWINPAK DEVICE
• 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: 22146192
• Report Number: 1213809-2025-00374
• Device Sequence Number: 15530880
• Product Code: FMI
• UDI-Device Identifier: 00382903033935
• UDI-Public: (01)00382903033935
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown