MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ NEEDLE ECLIPSE 21X1-1/2 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305765
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd¿ needle eclipse 21x1-1/2 rb tw had a safety failure.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
H.6.Investigation summary: since no lot number, photos, or samples displaying the condition reported are available 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.There was no quality notification was raised for a similar non ¿ conformance for the past one year.
Event or Problem Description
It was reported that bd¿ needle eclipse 21x1-1/2 rb tw had a safety failure.No serious injury or medical intervention was reported.

• Brand Name: BD¿ NEEDLE ECLIPSE 21X1-1/2 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8286405
• Report Number: 8041187-2019-00118
• Device Sequence Number: 2434972
• Product Code: FMI
• UDI-Device Identifier: 30382903057659
• UDI-Public: 30382903057659
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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 Catalogue Number: 305765
• Device Lot Number: 8608562
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/11/2019
• 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