MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305763
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no sample is returned.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of package damaged / defective / other with lot #9056795 regarding item #305763.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of shield missing with lot #9056795 regarding item #305763.Investigation conclusion: unable to confirm the customer experience as no photo/ sample was returned for investigation.Root cause description: root cause could not be determined.The complaint will be re-open and re-investigated if photo / sample is returned.Rationale: the complaint will continue to be tracked and monitored.
Event or Problem Description
It was reported that needle eclipse 22x1-1/2 rb came without a shield.This was discovered before use.The following information was provided by the initial reporter: material no.: 305763, batch no.: 9056795.It was reported that the needle was found without a shield and already open.Per email: one of the techs opened an angio pack, and found out one of the safety needles without a cap and open.He did not stick himself, but thought we should report for quality.

• Brand Name: NEEDLE ECLIPSE 22X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9873837
• Report Number: 8041187-2020-00164
• Device Sequence Number: 19540109
• Product Code: FMI
• UDI-Device Identifier: 30382903057635
• UDI-Public: 30382903057635
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/09/2020

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: 02/28/2024
• Device Model Number: 305763
• Device Catalogue Number: 305763
• Device Lot Number: 9056795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/24/2020
• 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