MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305758
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd eclipse¿ needle labeling had no eu importer information.The following information was provided by the initial reporter: "no eu importer is present on the labeling".
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation.A device history record could not be evaluated as the lot number is unknown.The regulatory information was reviewed, and there is no compliance issue with the product and labeling as it meets mdd requirements.Mdr certification is not plant based and manufacturers are able to produce mdd product until the mdd certification is expired.Tuas sku is ce certified under mdd and has not yet fully transitioned to mdr.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that the bd eclipse¿ needle labeling had no eu importer information.The following information was provided by the initial reporter: "no eu importer is present on the labeling".

• Brand Name: BD ECLIPSE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12334810
• Report Number: 8041187-2021-00737
• Device Sequence Number: 16818302
• Product Code: FMI
• UDI-Device Identifier: 30382903057581
• UDI-Public: 30382903057581
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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 Model Number: 305758
• Device Catalogue Number: 305758
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1