MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE; PISTON SYRINGE

Model Number	305782
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd eclipse¿ needle 23 g x 1 in.With detachable 3 ml bd luer-lok¿ syringe the stopper separated from the plunger.There was no report of patient impact.The following information was provided by the initial reporter: disconnect between plunger and stopper.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 26-jan-2023.H6: investigation summary our quality engineer inspected the 1 photo and 1 sample submitted for evaluation.The reported issue of stopper separation from plunger was confirmed upon inspection of the sample.Analysis of the sample showed that the stopper is separated from plunger.The plunger of the sample was subjected to visual inspection and short molding at plunger head was observed.The separation between stopper and plunger is due to short molding at the plunger head.Short molding on the plunger head could have happened during machine start-up.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
It was reported while using bd eclipse¿ needle 23 g x 1 in.With detachable 3 ml bd luer-lok¿ syringe the stopper separated from the plunger.There was no report of patient impact.The following information was provided by the initial reporter: disconnect between plunger and stopper.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document#: (b)(4) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: eclipse.Device failure: stopper separation.
Event or Problem Description
No additional information.

• Brand Name: BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• 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: 16261158
• Report Number: 8041187-2023-00024
• Device Sequence Number: 6728725
• Product Code: FMF
• UDI-Device Identifier: 30382903057826
• UDI-Public: (01)30382903057826
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

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 Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: 2070782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 03/02/2023; Not provided
• Initial Report FDA Received Date: 01/28/2023
• Supplement Report FDA Received Date: 03/19/2023; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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