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

Model Number	305767
Medical Device Problem Codes	Break (1069); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Investigation summary: one photo of the top web was received by our quality team for evaluation.No photos or samples of the nonconformance 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.Investigation conclusion: probable root cause: based on device history record review, no abnormality was observed during the production of the affected batches.From the photo, only the topweb was shown.Unable to observe the reported defect.Root cause is therefore not established.The complaint will be re-opened and re-investigated when sample is received.
Event or Problem Description
It was reported that at least one bd eclipse¿ needle experienced a broken safety mechanism.The following information was provided by the initial reporter: they are breaking off when staff pushes the pink safety part back/down so the surgeon can inject local.It was reported to me that there is an issue with the substitute we have for one of our hypos.Apparently, the safety piece (pink piece) can unexpectedly break off.I surveyed other staff members and they all have had the same experience.Luckily, no harm was actually done to staff nor patient.

• 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: 12137353
• Report Number: 8041187-2021-00572
• Device Sequence Number: 3800450
• Product Code: FMI
• UDI-Device Identifier: 30382903057673
• UDI-Public: 30382903057673
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 07/31/2025
• Device Model Number: 305767
• Device Catalogue Number: 305767
• Device Lot Number: 0206571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1