MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 22X1-1/2 RB; NEELDE

Catalog Number	305763
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that two needle eclipse 22x1-1/2 rb experienced safety failure.
Additional Manufacturer Narrative
Investigation: 100 representative samples in a shelf carton were received for evaluation.All 100 samples were subjected to visual inspection.There were no deformation/damage observed on the eclipse hub and safety shield.No breakage observed on the safety lock pin.10 samples were sent for ct scan for roundness and rod od measurements.The roundness and rod od results met the specifications requirement.20 samples were manually activated in accordance with the instruction for use (ifu) with no abnormalities observed.10 samples were activated per test method procedure, it377.The activation force results met the specification requirements.No assignable root cause could be established as the investigation revealed no abnormalities associated with the returned representative samples and all tested samples have passed the inspection.Dhr review was done and no quality notifications for similar defects were found for any of the batches.
Event or Problem Description
It was reported that two needle eclipse 22x1-1/2 rb experienced safety failure.

• Brand Name: NEEDLE ECLIPSE 22X1-1/2 RB
• Common Device Name: NEELDE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8384135
• Report Number: 8041187-2019-00180
• Device Sequence Number: 13508438
• Product Code: FMI
• UDI-Device Identifier: 30382903057635
• UDI-Public: 30382903057635
• 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
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 305763
• Device Lot Number: 8207153
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/15/2019
• 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