MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA FINE INSULIN SYRINGE; PISTON SYRINGE

Model Number	329416
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that an unspecified number of bd ultra fine¿ insulin syringes experienced foreign matter contamination and difficult plunger movement.Product defects were noted during use.The following information was provided by the initial reporter: material no: 329416, batch no: 9028862.Consumer reported finding two syringes with something black on the inside of the barrel.The syringes have not been used.Stated, it looks like something melted on inside, black in color.Stated, the plunger was hard to move.Date of event: 2020 (b)(6).
Event or Problem Description
It was reported that an unspecified number of bd ultra fine¿ insulin syringes experienced foreign matter contamination and difficult plunger movement.Product defects were noted during use.The following information was provided by the initial reporter: material no: 329416 batch no: 9028862.Consumer reported finding two syringes with something black on the inside of the barrel.The syringes have not been used.Stated, it looks like something melted on inside, black in color.Stated, the plunger was hard to move date of event: (b)(6) 2020.
Additional Manufacturer Narrative
Investigation: no samples (including photos) were returned as of 19 june 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9028862.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted for smeared stoppers.There were two (2) notifications [(b)(4)] noted for out of spec breakout/ sustaining.There was one (1) notification [(b)(4)] noted for grease on barrel.

• Brand Name: BD ULTRA FINE INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10106960
• Report Number: 1920898-2020-00599
• Device Sequence Number: 17053152
• Product Code: FMF
• UDI-Device Identifier: 00382903294169
• UDI-Public: 00382903294169
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Model Number: 329416
• Device Catalogue Number: 329416
• Device Lot Number: 9028862
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other