MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL EUROGRAPHICS; PISTON SYRINGE

Catalog Number	300912
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
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 syringe 10ml ll eurographics had label content missing.The following information was provided by the initial reporter translated from french to english: 14 10ml ll syringes, reference 300912, have been returned to us because the lot number and expiration date were missing from the packaging (see attached photo).Return address for retained samples: (b)(6).Additional information provided: can you confirm whether samples are available for the survey? yes, if yes, please specify whether the samples are unused (before use): unused used (during or after use) important: if used, please confirm whether the samples are contaminated with blood or cytotoxic drugs.If you have retained a sample for investigation, please provide us with the collection address (full details - please use the template below).To ensure easy collection, we strongly recommend that you provide an easily accessible location, such as the hospital pharmacy, your goods in/out department, mailroom or main reception.The address should not be inside the hospital unit (maternity, oncology, etc.).(b)(6).Please also provide us with the telephone number of a person who can be contacted by the carrier.Name of person to contact: (b)(6).An empty shipping box complying with the regulations, accompanied by the necessary accessories, will be delivered to the same address.We will organise collection of the sample by our carrier.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Supplemental mdr - label content missing.Fourteen samples and one photo were provided to our quality team for investigation.All samples were received sealed with all applicable information/variable data missing.The photo shows one package with all variable data missing.The condition observed is non-conforming per product specification.Potential root cause for the label content missing defect is associated with the packaging process.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 EUROGRAPHICS
• Common Device Name: PISTON SYRINGE
• 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: 21414749
• Report Number: 1213809-2025-00113
• Device Sequence Number: 9345680
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: (01)30382903009122
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: 300912
• Device Lot Number: UNKNOWN
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 05/02/2025
• 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