MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS; PISTON SYRINGE

Model Number 328468

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Fda device problem code: 2944.Fda patient problem code: 2645.

Event Description

It was reported that syringe 0.5ml 31ga 8mm ufii 10bag 500cs had foreign matter.The following information was provided by the initial reporter: material no.328468 batch no.0132242 it was reported that when drawing up insulin there was a deep colored turquoise colored liquid that came out.

Manufacturer Narrative

Investigation summary: customer returned (1) loose 1/2cc, 89mm syringe.Customer states that when drawing up insulin there was a deep colored turquoise colored liquid that came out.The returned syringe was examined and was returned with approximately 20 units of a blue liquid in the barrel.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely insulin, which would not have been acquired during the manufacturing process.A review of the device history record was completed for batch# 0132242.All inspections and challenges were performed per the applicable operations qc specifications.There was one notification [200894774] noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure root cause cannot be determined at this time as the blue liquid would not have been acquired during the manufacturing process.

Event Description

It was reported that syringe 0.5ml 31ga 8mm ufii 10bag 500cs had foreign matter.The following information was provided by the initial reporter: material no.328468 batch no.0132242.It was reported that when drawing up insulin there was a deep colored turquoise colored liquid that came out.

• Brand Name: SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10872952
• MDR Text Key: 218254204
• Report Number: 1920898-2020-01599
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328468
• Device Catalogue Number: 328468
• Device Lot Number: 0132242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1