MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK SYRINGE WITH THE BD ECLIPSE SAFETY THIN WALL NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305787
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987.(syringe) pma / 510(k)#: k161170.(needle) 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 safety mechanism on the bd luer-lok¿ syringe with the bd eclipse¿ safety thin wall needle snapped off while attempting to engage it.The following information was provided by the initial reporter: "bd eclipse needle, 25g, 0.5mmx25mm safety mechanism snapped off from needle head while i attempted to engage safety mechanism with forefinger.Almost pricked myself with the needle.Was not able to engage safety mechanism, threw needle into sharps bin.".
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the safety mechanism on the bd luer-lok¿ syringe with the bd eclipse¿ safety thin wall needle snapped off while attempting to engage it.The following information was provided by the initial reporter: "bd eclipse needle, 25g, 0.5mmx25mm safety mechanism snapped off from needle head while i attempted to engage safety mechanism with forefinger.Almost pricked myself with the needle.Was not able to engage safety mechanism, threw needle into sharps bin.".

• Brand Name: BD LUER-LOK SYRINGE WITH THE BD ECLIPSE SAFETY THIN WALL NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12103694
• Report Number: 8041187-2021-00554
• Device Sequence Number: 19788315
• Product Code: FMI
• UDI-Device Identifier: 30382903057871
• UDI-Public: 30382903057871
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.10.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 305787
• Device Catalogue Number: 305787
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1