MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE; SAFETYGLIDE NEEDLES

Catalog Number 305950

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that the bd safetyglide had a needle shielding failure.The following was provided by the initial reporter: "hi, i was giving an injection yesterday and one of the needle safety failed.It was stuck and would not release to cover the needle.No one was injured and the needle was safely disposed of but i was wondering if i need to do a verge or contact anyone regarding this? there was no other needles in that box with that issue.Lot # 3198139".

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD SAFETYGLIDE
• Type of Device: SAFETYGLIDE NEEDLES
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18692390
• MDR Text Key: 336327908
• Report Number: 1920898-2024-00050
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305950
• Device Lot Number: 3198139
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1