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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
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: we received a case of bd 10ml twinpak syringes (ref (b)(4)) last week, and they came in packaging for the 5ml twinpaks (ref (b)(4)).Lot number on the outside of the box was 5065846.Just a head up.Additional information provided: the issue was found 05-02-2025 after receipt of the item.Photos are attached.If you zoom in you can see there is a 10 ml syringe in the 5 ml packaging.
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
No additional information was provided.
Additional Manufacturer Narrative
(b)(6) supplemental mdr - label content incorrect.One hundred samples and two photos of 10ml twinpak syringes (part number: 303393) from batch: 5065846 were received and evaluated.All samples arrived in sealed packages within a single case box and were confirmed to contain 10ml syringes.However, the top web labeling on all packages incorrectly indicated 5ml.Two photos show a box of 10 ml twinpak syringes alongside a sealed package.One photo displays the front of the package, and the other shows the back.Both clearly indicate that the top web graphics are for a 5 ml syringe, while the syringe inside is 10 ml.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.

• 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: 22092734
• Report Number: 1213809-2025-00352
• Device Sequence Number: 17879415
• Product Code: FMI
• UDI-Device Identifier: 00382903033935
• UDI-Public: (01)00382903033935(11)250306(17)300228(10)5065846
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/06/2025

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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/10/2025
• 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