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

Catalog Number	305768
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 twenty-two bd¿ eclipse needles had drops of blood splatter when the safety devices were activated.
Additional Manufacturer Narrative
Investigation summary: a device history record review was performed and showed no non-conformance's associated with this issue during the production of this batch.Since no samples displaying the condition reported were returned for examination, we were unable to fully investigate this incident.Root cause could not be determined as there is no sample returned for investigation.During outgoing inspection, there was no abnormality observed during visual inspection.For the duration of the last 12 months, there was no quality notification raised for a similar non-conformance.
Event or Problem Description
It was reported that twenty-two bd¿ eclipse needles had drops of blood splatter when the safety devices were activated.

• Brand Name: BD¿ ECLIPSE NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8283735
• Report Number: 8041187-2019-00117
• Device Sequence Number: 159236
• Product Code: FMI
• UDI-Device Identifier: 30382903057680
• UDI-Public: 30382903057680
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/12/2019

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: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 305768
• Device Lot Number: 8207154
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/12/2019
• 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