MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305782
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our quality engineer inspected the photo submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.We appreciate you taking the time to bring this observation to our attention.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.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl eclipse 23x1 rb had foreign matter.Foreign body in the syringe - on the plunger.
Additional Manufacturer Narrative
The reported issue of foreign matter was confirmed upon inspection of the sample.Analysis of the sample showed brown foreign matter with unknown liquid in the syringe barrel.Fourier transform infrared spectroscopy (ftir) analysis was performed to determine the foreign matter type.The ftir results shows that the foreign matter spectrum matches reasonably with a mixture of protein and an unknown material.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.The manufacturing process was reviewed.The team inspected the production line, and no abnormality was observed during the production run.The probable root cause could be material handling or transportation.Communication will be issued to all production associate to raise awareness on the observed defect.
Event or Problem Description
On the plunger.

• Brand Name: SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20226283
• Report Number: 2243072-2024-00969
• Device Sequence Number: 16992608
• Product Code: FMI
• UDI-Device Identifier: 00382903057825
• UDI-Public: (01)00382903057825
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: Health Professional
• Device Catalogue Number: 305782
• Device Lot Number: UNKNOWN
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown