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

Model Number	305765
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd eclipse¿ needle safety shield was found detached before use.The following information was provided by the initial reporter: "we continue to find unacceptable units (missing safety shield) in lot number 8171369.".
Additional Manufacturer Narrative
H.6.Investigation summary: one photo sample was received by our quality team for evaluation.From the photo, signs of the safety shield being broke off and missing from the unit package was observed.The customer experience was confirmed from the photo evaluation.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The primary packaging process was reviewed.There is a safety shield presence sensor to detect for missing safety shield and auto-reject the part.The sensor was challenged and able to auto-reject the part.The safety shield could have experienced signs of breakage during exercising motion and dropped off when moving to the next station.Reviewed the molding first piece report and the roundness and rod od measurements were within specification.Root cause could not be determined for safety shield broke off as no sample is returned for investigation.There is a vision system at the primary packaging machine to check for missing safety shield.Upon detected missing shield, the vision system will trigger the machine to stop.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd eclipse¿ needle safety shield was found detached before use.The following information was provided by the initial reporter: "we continue to find unacceptable units (missing safety shield) in lot number 8171369.".

• 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: 10243051
• Report Number: 8041187-2020-00388
• Device Sequence Number: 16795220
• Product Code: FMI
• UDI-Device Identifier: 30382903057659
• UDI-Public: 30382903057659
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (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): 07/30/2020

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: 06/30/2023
• Device Model Number: 305765
• Device Catalogue Number: 305765
• Device Lot Number: 8171369
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other