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

Catalog Number	305781
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: unknown.The date received by manufacturer has been used for this field.H3: 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 while drawing up vaccine medicine, the bd luer-lock¿ syringe with eclipse¿ needle plunger was crooked and difficult to move.The following information was provided by the initial reporter: "description of complaint: when drawing up vaccinations that the plungers were slightly cooked and therefore could not be used in the clinic.Every piece of this item was pulled immediately, so a not to cause harm to any patients or staff.Are you able to provide the date of the event? between the period of (b)(6) 2023 to (b)(6) 2023 did you experience any adverse events as a result of this reported defect? no was there any patient impact or patient involvement? no.".
Event or Problem Description
It was reported that while drawing up vaccine medicine, the bd luer-lock¿ syringe with eclipse¿ needle plunger was crooked and difficult to move.The following information was provided by the initial reporter: "description of complaint: when drawing up vaccinations that the plungers were slightly cooked and therefore could not be used in the clinic.Every piece of this item was pulled immediately, so a not to cause harm to any patients or staff.Are you able to provide the date of the event? between the period of august 3, 2023 to august 15, 2023.Did you experience any adverse events as a result of this reported defect? no.Was there any patient impact or patient involvement? no".
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 19-sep-2023.H.6.Investigation summary: our quality engineer inspected the 1 photo and 140 representative samples submitted for evaluation.The reported issue of plunger rod broken/ damaged was not confirmed upon inspection of the photo and samples.Analysis of the samples showed no damages or defects.The samples passed visual inspection where no abnormalities were observed.The root cause could not be determined as the defect could not be replicated.Production records were reviewed, and this batch meets our manufacturing specification requirements.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.H3 other text : see h10.

• Brand Name: BD ECLIPSE¿ NEEDLE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17770097
• Report Number: 8041187-2023-00493
• Device Sequence Number: 17910608
• Product Code: FMI
• UDI-Device Identifier: 00382903057818
• UDI-Public: 00382903057818
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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 Catalogue Number: 305781
• Device Lot Number: 2234200
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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