MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 23 G X 1 IN. SINGLE USE STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305762
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of safety mechanism failure (eclipse) was not confirmed upon inspection of the photo.The photo provided did not clearly display the reported defect.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Based on device history record review, no abnormality was observed during the production of the affected batches.Examination of the actual product involved may provide clarification as to the cause of the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported by the customer that the bd eclipse¿ needle 23 g x 1 in.Single use sterile was coming off during activation.The following information was provided by the initial reporter: safety arm of eclipse needle is coming off during activation.

• Brand Name: BD ECLIPSE¿ NEEDLE 23 G X 1 IN. SINGLE USE STERILE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15784876
• Report Number: 8041187-2022-00661
• Device Sequence Number: 3010430
• Product Code: FMI
• UDI-Device Identifier: 00382903057627
• UDI-Public: 00382903057627
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• 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): 11/04/2022

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: 305762
• Device Lot Number: 1301511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown