MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305780
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 2 bd eclipse¿ needle with detachable bd luer-lok¿ syringes had difficult plunger movement during use.The following information was provided by the initial reporter: "plungers is hard to push".
Event or Problem Description
It was reported that 2 bd eclipse¿ needle with detachable bd luer-lok¿ syringes had difficult plunger movement during use.The following information was provided by the initial reporter: "plungers is hard to push".
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.Investigation summary: our quality engineer inspected the 1 photo and 2 samples submitted for evaluation.The reported issue of plunger movement difficult was confirmed upon inspection of the samples.The syringes were received with opened packaging and the eclipse needle was missing.The stopper on the end of the plunger is not flat on the tip and is considered jammed.The plunger was slightly hard to push.One image shows the two syringes in their package with the eclipse needles missing.The reported defects cannot be confirmed with this image.Another photo shows two loose 1ml syringes with the plunger drawn back until the stopper rests at the 0.5ml.The tip of the stopper is not flat on one of the syringes and the other looks acceptable.The third image shows two loose syringes with the plunger rods bottomed out at the end of the syringes and one is not flat, and the other looks acceptable.Bd determined that the cause of the potential root cause for the jammed stopper defect is associated with the assembly process.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE
• 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: 16236831
• Report Number: 8041187-2023-00013
• Device Sequence Number: 6870951
• Product Code: FMI
• UDI-Device Identifier: 00382903057801
• UDI-Public: 00382903057801
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 08/31/2026
• Device Catalogue Number: 305780
• Device Lot Number: 1237349
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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