MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ NEEDLE ECLIPSE 21X1 RB TW; HYPODERMIC NEEDLE

Catalog Number	305764
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 a bd¿ needle eclipse 21x1 rb tw had a failure safety shield.
Additional Manufacturer Narrative
No sample was returned for investigation.The non-conformance could not be confirmed.During the review of dhr, there was no failure observed on the hub hook breakage and safety shield fall off/break off test which was performed during out-going inspection.There was also no abnormality observed during the needle shield pull force test during functional test.(b)(4) has been raised to address safety shield disengagement issue.The affected batch was produced before the capa implementation.
Event or Problem Description
It was reported that a bd needle eclipse 21x1 rb tw had a failure safety shield.
Event or Problem Description
It was reported that a bd needle eclipse 21x1 rb tw had a failure safety shield.
Additional Manufacturer Narrative
Date received by manufacturer: 11/08/2018.

• Brand Name: BD¿ NEEDLE ECLIPSE 21X1 RB TW
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8096562
• Report Number: 8041187-2018-00430
• Device Sequence Number: 1833810
• Product Code: FMI
• UDI-Device Identifier: 30382903057642
• UDI-Public: 30382903057642
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2018

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: 02/28/2023
• Device Catalogue Number: 305764
• Device Lot Number: 8052431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018; 11/08/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/12/2018; 12/19/2018
• 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