MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD MICRO-FINE IV NEEDLE; PISTON SYRINGE

Model Number	329461
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	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 5 bd insulin syringes with the bd micro-fine¿ iv needle had excess silicone in the fluid pathway.The following information was provided by the initial reporter: "i don't think that it's water, i believe it to be excess silicone oil to lubricate the syringe.".
Additional Manufacturer Narrative
H.6.Investigation: customer returned two images of two 0.5ml syringes.Each of these syringes features a bead of a clear material midway along the length of the needle.This material may be excessive adhesive.A review of the device history record was completed for batch# 0132264.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.There was one (1) notification noted for excessive silicone.Based on the images received, bd was able to confirm the customer¿s indicated failure of foreign matter at the cannula.There were no notifications or maintenance dispatches during the time of this batch that pertained to the defect.No root cause can be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that 5 bd insulin syringes with the bd micro-fine¿ iv needle had excess silicone in the fluid pathway.The following information was provided by the initial reporter: "i don't think that it's water, i believe it to be excess silicone oil to lubricate the syringe.".

• Brand Name: BD INSULIN SYRINGE WITH THE BD MICRO-FINE IV NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12147604
• Report Number: 1920898-2021-00740
• Device Sequence Number: 17197362
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 07/31/2025
• Device Model Number: 329461
• Device Catalogue Number: 329461
• Device Lot Number: 0132264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1