MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML S/T 200 S/C; PISTON SYRINGE

Catalog Number	303134
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #:303134.Batch#:4078418.It was reported that the bd syringe 10ml s/t 200 s/c label content was incorrect.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.We have some product labeled with the european acceptance symbol (ce) while other packages do not have this labeling and instead say ¿rx only¿.Lot numbers are different between the two and the rx only labels have slightly different mm readings for the measurement.The item numbers on both are the same, and the expiration dates are similar, so i assume they were manufactured at similar times (especially the 2.5¿ needles in the middle row).Our team is wondering about this packaging change and when it may have occurred, so if the difference in packaging represents the products being manufactured in different factories.Product#: 303134.Lot#: 4078418.
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.
Additional Manufacturer Narrative
No samples or photos received by our quality team for evaluation.The reported condition is acceptable per product specification.This product code does not require a ce mark on the package.Product graphics are determined by regulatory requirements by the country in which they are sold.Batch 4078418 is considered in compliance with our product specification requirements.We appreciate you taking the time to bring this observation to our attention.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 S/T 200 S/C
• 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: 20751082
• Report Number: 1213809-2024-00862
• Device Sequence Number: 17246532
• Product Code: FMF
• UDI-Device Identifier: 00382903031344
• UDI-Public: (01)00382903031344(11)240318(17)290228(10)4078418
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 303134
• Device Lot Number: 4078418
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown