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

Catalog Number	305763
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: 2 representative samples of batch 5141109 were returned in sealed packages for investigation.The safety shields were found to be intact and passed safety shield test.A review of the device history record revealed no irregularities during the manufacture of the reported lot numbers.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment.Bd was unable to duplicate or confirm the customer's indicated failure more, therefore a root cause cannot be determined.Capa (b)(4) was initiated for this issue to document the investigation path, root cause analysis and remediation plan to include corrective and preventive actions.
Event or Problem Description
It was reported that the safety shield on a bd eclipse¿ hypodermic needle fell off before use.There was no report of injury or medical intervention.

• Brand Name: BD ECLIPSE¿ HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7173024
• Report Number: 8041187-2017-00282
• Device Sequence Number: 1952303
• Product Code: FMI
• UDI-Device Identifier: 30382903057635
• UDI-Public: 30382903057635
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: Nurse
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 305763
• Device Lot Number: 5141109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/08/2018
• 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