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	04/23/2025
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.It was reported by the customer that the correct item# on the outside box does not match the inside item.Verbatim: we have received a quality complaint on product sold to our customer.Please contact the customer and include complaint# (b)(4) on any future communications.Injuries or adverse event: no.Po: (b)(4).Item: 303393.Reported issue: recvd b-d303393 that notes the correct item# on the outside box, however the inside item is marked b-d303392.Are any samples available for return? yes.Customer disposition request: replacement.Quantity affected: (b)(4).Serial/lot number: (b)(6).
Additional Manufacturer Narrative
(b)(4).Supplemental mdr - label content incorrect.Four hundred samples and two photographs 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, creating a labeling discrepancy.One image showed three cartons labeled as 10ml, while the other showed the top carton opened, revealing internal packaging with 5ml top web graphics.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: 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: 22014473
• Report Number: 1213809-2025-00338
• Device Sequence Number: 7837737
• 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: ME
• 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,Followup
• Report Date (Section B): 06/03/2025

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: Other
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/09/2025
• 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