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

Catalog Number	305788
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	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign, oil-like residue was found on the plunger of the bd eclipse¿ injection needle with luer-lock¿ syringe while drawing up medication.The following information was provided by the initial reporter: "this morning, a nurse brought something to my attention about these specific bd syringes.Their primary purpose is for subcutaneous heparin injection.When the nurse began to draw the medication up into the syringe, she noticed an oil like residue on the plunger of the syringe when it was pulled back.We don¿t believe we¿ve seen anything like this on any of the other syringes we use on the unit, so we wanted to bring this forward to you in case this is some sort of defect.".
Additional Manufacturer Narrative
The reported lot# 1201099 was not found for the reported catalog# 305788.Medical device expiration date: unknown.Initial reporter phone#: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary : our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of foreign matter was confirmed upon review of the supplied photos and complaint records.Analysis of previous records showed that excessive lubricant was present on the plunger of the syringe.Bd determined that the cause of the failure was related to the manufacturing process.Silicone is used as a lubricant during manufacturing and excess silicone can be applied to the product, resulting in what appears to be an oily substance.Corrective actions have been made to address this issue.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch was in compliance with our product specification requirements.
Event or Problem Description
It was reported that foreign, oil-like residue was found on the plunger of the bd eclipse¿ injection needle with luer-lock¿ syringe while drawing up medication.The following information was provided by the initial reporter: "this morning, a nurse brought something to my attention about these specific bd syringes.Their primary purpose is for subcutaneous heparin injection.When the nurse began to draw the medication up into the syringe, she noticed an oil like residue on the plunger of the syringe when it was pulled back.We don¿t believe we¿ve seen anything like this on any of the other syringes we use on the unit, so we wanted to bring this forward to you in case this is some sort of defect.".

• Brand Name: BD ECLIPSE¿ INJECTION NEEDLE WITH LUER-LOCK¿ 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: 15709760
• Report Number: 8041187-2022-00636
• Device Sequence Number: 12384622
• Product Code: FMI
• UDI-Device Identifier: 00382903057887
• UDI-Public: (01)00382903057887
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 11/04/2022

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: Health Professional
• Device Catalogue Number: 305788
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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