MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ SAFETY NEEDLES BD ECLIPSE¿ NEEDLE; PISTON SYRINGE

Model Number	305780
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd eclipse¿ safety needles bd eclipse¿ needle plunger was difficult to push.The following information was provided by the initial reporter: "plunger is hard to push".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 29-mar-2022.H.6.Investigation: one photo and one sample were received by our quality team for evaluation.From the photo, plunger stop at approximate scale marking 0.62 ml from the photo, but the team was unable to determine difficult plunger movement.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The 1 ml syringe part is manufactured at bd canaan, and the bd canaan quality has conducted a supplemental investigation on this nonconformance.The sample was received with the opened package 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.The photo shows a loose 1ml luer-lok syringe with the plunger drawn back until the stopper rests at 0.6 ml.The tip of the stopper is not flat.A potential root cause for the jammed stopper defect is associated with the assembly process.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd eclipse¿ safety needles bd eclipse¿ needle plunger was difficult to push.The following information was provided by the initial reporter: "plunger is hard to push".

• Brand Name: BD ECLIPSE¿ SAFETY NEEDLES BD ECLIPSE¿ NEEDLE
• 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: 13934926
• Report Number: 8041187-2022-00153
• Device Sequence Number: 4886797
• Product Code: FMF
• UDI-Device Identifier: 30382903057802
• UDI-Public: 30382903057802
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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 Expiration Date: 08/31/2026
• Device Model Number: 305780
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/21/2022
• 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