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

Catalog Number	305769
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
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 loosened after use while retracting the bd eclipse¿ needle.The following information was provided by the initial reporter, translated from (b)(6) to english: "it's noticed that safety mechanism on the eclipse needle loosen after needle retraction".
Event or Problem Description
It was reported that the safety mechanism loosened after use while retracting the bd eclipse¿ needle.The following information was provided by the initial reporter, translated from chinese to english: "it's noticed that safety mechanism on the eclipse needle loosen after needle retraction".
Additional Manufacturer Narrative
Investigation: one actual unused sample in opened package was received for investigation.Our quality engineer inspected the returned units 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-conformance's 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: 8791426
• Report Number: 8041187-2019-00541
• Device Sequence Number: 3205937
• Product Code: FMI
• UDI-Device Identifier: 30382903057697
• UDI-Public: 30382903057697
• 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,health professional,o
• Initial Reporter Occupation: Nurse
• 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: 09/30/2022
• Device Catalogue Number: 305769
• Device Lot Number: 7268011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/15/2019
• 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