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

Catalog Number	305763
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a nurse sustained a dirty needle stick injury from the bd eclipse¿ hypodermic needle during an "emergency im injection to an agitated resident".A "portion of the plastic cover" failed to shield part of the needle once activated, resulting in a prick to the nurse's hand.However, no medical intervention was reported.
Event or Problem Description
It was reported that a nurse sustained a dirty needle stick injury from the bd eclipse¿ hypodermic needle during an "emergency im injection to an agitated resident".A "portion of the plastic cover" failed to shield part of the needle once activated, resulting in a prick to the nurse's hand.However, no medical intervention was reported.
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.The complaint is unconfirmed as no defect is observed on the sample.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.A dhr was performed and no qn's were observed relating to the reported defect on any of the batches.

• Brand Name: BD ECLIPSE¿ HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8370354
• Report Number: 8041187-2019-00169
• Device Sequence Number: 16418385
• 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: 02/26/2019
• 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