MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE; INSULIN SYRINGE AND NEEDLE

Catalog Number 305934

Device Problem Retraction Problem (1536)

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

Event Date 02/06/2018

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 before use of the bd safetyglide¿ insulin syringe there was a ¿retraction failure for cannula.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned one bd 1/2cc safetglide insulin syringe without the packaging or shield.Customer states that there is a retraction failure for the cannula.The returned syringe was tested and the safety mechanism was able to be activated without observed defects.As per manufacturing, a review of the device history record was completed for batch# 7139826.All inspections and challenges were performed per the applicable operations qc specifications.There were no notifications noted that pertained to the complaint investigation conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7285983
• MDR Text Key: 100727841
• Report Number: 1920898-2018-00110
• Device Sequence Number: 1
• Product Code: FMF
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 305934
• Device Lot Number: 7139826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Date Manufacturer Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other