MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE W/ ATTACHED NEEDLE; SYRINGE, ANTISTICK

Model Number 367986

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2020

Event Type  malfunction  

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 Description

It was reported that no aspiration occurred during use with a 1/2 ml bd safetyglide¿ insulin syringe w/ attached needle.The following information was provided by the initial reporter, "syringe does not aspirate.".

Manufacturer Narrative

H.6.Investigation summary customer returned one (1) used 30gx8mm, 0.5ml bd safetyglide insulin syringe from an open blisterpack from lot 8211636.Consumer reported syringe does not aspirate.The returned syringe was examined and it was observed that the safety mechanism had been activated.After disabling the safety mechanism the syringe was tested for flow: the syringe was unable to draw or expel properly.A wire test was then performed on this sample: the wire passed through the cannula, however, there was a small, clear residue observed at the tip of the wire after being through the cannula.Under the microscope the residue was identified as residual silicone from the manufacturing process.The clog would be the cause for no flow through the syringe.A review of the device history record was completed for batch# 8211636.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion bd was able to duplicate or confirm the customer¿s indicated failure (clog).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description after visual evaluation of the sample and from level a investigation report on (1) syringe returned from the customer appeared to have silicone clog inside the cannula.A wire test was then performed: the wire passed through the cannula, however there was a small, clear residue observed a tip of the wire.Under the microscope the residue was identified as residual silicone.This clog would be the cause for the syringe to not draw properly (as reported).Process: ¿ the racks carrying the hub with cannula move further down along a rail, a pullout device moves the cannula out a small distance for adhesive to be applied.¿ during the parts pass under the corona treater pins and exposed to an ion rich corona field, which increases surface energy wettability to aid in the adhesion of the adhesive to the hub.¿ the cannula is then re-inserted into the hub with vacuum.The pim inspection systems looks for adhesive clogs and rejects the needle assemblies in the process.Rationale based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that no aspiration occurred during use with a 1/2 ml bd safetyglide¿ insulin syringe w/ attached needle.The following information was provided by the initial reporter, "syringe does not aspirate.".

• Brand Name: 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE W/ ATTACHED NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9820000
• MDR Text Key: 196097744
• Report Number: 1920898-2020-00237
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• Combination Product (y/n): N
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: 367986
• Device Catalogue Number: 305934
• Device Lot Number: 8211636
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other