MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE INSULIN SYRINGE WITH NEEDLE; ANTISTICK SYRINGE

Catalog Number 305934

Device Problem Failure to Deliver (2338)

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

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

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 the bd safetyglide¿ insulin syringe with needle could not be aspirated before use.The following information was provided by the initial reporter: "the syringe cannot be vented.".

Manufacturer Narrative

Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# (b)(4).All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

Event Description

It was reported that the bd safetyglide¿ insulin syringe with needle could not be aspirated before use.The following information was provided by the initial reporter: "the syringe cannot be vented.".

• Brand Name: BD SAFETYGLIDE INSULIN SYRINGE WITH NEEDLE
• Type of Device: ANTISTICK SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8975691
• MDR Text Key: 156968270
• Report Number: 1920898-2019-00941
• Device Sequence Number: 1
• Product Code: MEG
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 305934
• Device Lot Number: 8266741
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other