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

Catalog Number	305763
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
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 the safety mechanism did not work easily with a bd needle eclipse 22x1-1/2.The following information was provided by the initial reporter: (3 of 4 complaints) it was reported that safety mechanisms do not snap closed easily.We need to be able to single hand close the needle so we don¿t have to take the other hand off the patient (especially if it¿s a kicking/screaming child), however, using these needles we have to use both hands to ensure its locked.
Additional Manufacturer Narrative
H.6.Investigation summary: one representative samples were received for investigation.The one representative sample was subjected to visual inspection.There was no deformation/damage observed on the eclipse hub and safety shield.No breakage observed on the safety lock pin.A device history record review found no non-conformances associated with this issue during production of this batch.Conclusion: no assignable root cause could be established as the investigation revealed no abnormalities associated with the tested sample and the tested sample has passed the inspection.H3 other text : see section h.10.
Event or Problem Description
It was reported that the safety mechanism did not work easily with a bd needle eclipse 22x1-1/2.The following information was provided by the initial reporter: (3 of 4 complaints).It was reported that safety mechanisms do not snap closed easily.We need to be able to single hand close the needle so we don¿t have to take the other hand off the patient (especially if it¿s a kicking/screaming child), however, using these needles we have to use both hands to ensure its locked.

• Brand Name: BD NEEDLE ECLIPSE 22X1-1/2
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9234216
• Report Number: 8041187-2019-00846
• Device Sequence Number: 2605986
• Product Code: FMI
• UDI-Device Identifier: 30382903057635
• UDI-Public: 30382903057635
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 11/12/2019

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: 12/31/2023
• Device Catalogue Number: 305763
• Device Lot Number: 9006778
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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