MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 22X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305768
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.The customer's address is unknown:  (b)(6) has been used as a default.  fda notified: the initial reporter also notified the fda on (date) via (b)(4).Device manufacture date: unknown.(b)(4).Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Investigation conclusion: no photo/sample were returned for investigation.Root cause could not be determined.The complaint will be re-opened and re-investigated if the photo/sample is received.
Event or Problem Description
It was reported that the needle eclipse 22x1 rb experienced a safety mechanism that detached.The following information was provided by the initial reporter: material no:305768, batch no: unknown.After administering a flu vaccine, when attempting to engage the safety cap, it popped off bd eclipse needle 22g x 1.

• Brand Name: NEEDLE ECLIPSE 22X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10988673
• Report Number: 8041187-2020-00822
• Device Sequence Number: 16338354
• Product Code: FMI
• UDI-Device Identifier: 00382903057689
• UDI-Public: 00382903057689
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• 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
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305768
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1