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

Model Number	305787
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one photo was received by our quality team for evaluation.From the photo, the needle shield was observed to not be fully capped and seemed bowed.The cannula was observed to be bent at 90 degrees and pieced through the shield.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The cannula pierced through the shield could have occurred at the shield loading station of the assembly machine.From the returned photos, the needle shield seems bowed, however as no sample was received, this could not be confirmed.During the shield loading process, this bowed shield could have hit the cannula causing it to bend and pierce through the shield.Awareness training for this nonconformance will occur.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: based on device history record review, no abnormality was observed during the production of the affected batches.
Event or Problem Description
It was reported that the bd eclipse¿ needle experienced the needle penetrated through the shield.The following information was provided by the initial reporter: looks like the needle has come through the cap.No description on what happened.

• 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: 12250104
• Report Number: 8041187-2021-00657
• Device Sequence Number: 3223035
• Product Code: FMI
• UDI-Device Identifier: 30382903057871
• UDI-Public: 30382903057871
• 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
• Serviced by Third Party (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): 07/16/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 305787
• Device Catalogue Number: 305787
• Device Lot Number: 1055838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1