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

Catalog Number	305767
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd eclipse¿ needle was loose.This was discovered before use.The following information was provided by the initial reporter: it's noticed that safety mechanism on the eclipse needle loosen during the preparation of the injection.Defected product didn't used on patient.One sample from the same batch will be returned as sample for further investigation.
Event or Problem Description
It was reported that bd eclipse¿ needle was loose.This was discovered before use.The following information was provided by the initial reporter: it's noticed that safety mechanism on the eclipse needle loosen during the preparation of the injection.Defected product didn't used on patient.One sample from the same batch will be returned as sample for further investigation.
Additional Manufacturer Narrative
Investigation: one representative unused sample in sealed package was received for investigation.Our quality engineer inspected the returned unit and could not identify any manufacturing related defects or abnormalities.No issues with the safety shield or hub were observed.A device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.As a result, the root cause of the reported issue could not be determined.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8786446
• Report Number: 8041187-2019-00538
• Device Sequence Number: 16571083
• Product Code: FMI
• UDI-Device Identifier: 30382903057673
• UDI-Public: 30382903057673
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/12/2019

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: 10/31/2023
• Device Catalogue Number: 305767
• Device Lot Number: 8314981
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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