MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305762
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.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 needle eclipse 23x1 rb safety mechanism broke.The following information was provided by the initial reporter: it was reported by the medical professional, the safety popped off the needle ad fell to the ground.Reported issue per customer: product complaint ¿ faulty safety cap.The safety cap was bumped off the needle just after administering an injection.An ma was administering a vaccination to a young child.The child was unhappy after the needle stick and swung his arm bumping the syringe.The safety cap popped off the needle and fell to the ground.The cap came off far too easily.No caregivers or patients were harmed.The needle was disposed of in a sharps container and was not retained.

• Brand Name: NEEDLE ECLIPSE 23X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12749591
• Report Number: 8041187-2021-00947
• Device Sequence Number: 14665695
• Product Code: FMI
• UDI-Device Identifier: 00382903057627
• UDI-Public: 00382903057627
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 305762
• Device Lot Number: 0237455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1