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	11/22/2017
Type of Reportable Event	Malfunction
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 the safety mechanism on a bd eclipse¿ needle "flew off" when attempting to activate after an injection.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the returned unit and could not identify any manufacturing related defects.No damage was observed on the safety shield.The sample was subjected to safety shield fall off/break off test, no safety shield disengagement was observed.As a result, the root cause of the reported issue could not be determined.Dhr review showed no abnormality was reported on the affected batch during production.Customer complaint trends are evaluated on a monthly basis.Although the defect was not confirmed for this instance, bd has investigated a similar reported issue and corrective actions have been taken to prevent future occurrences of this type.Capa # (b)(4) has been initiated to address the issue.

• 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: 7470142
• Report Number: 8041187-2018-00141
• Device Sequence Number: 106918
• Product Code: FMI
• UDI-Device Identifier: 30382903057680
• UDI-Public: 30382903057680
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: 03/31/2021
• Device Catalogue Number: 305768
• Device Lot Number: 6088323
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 06/05/2018
• 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