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

Catalog Number	305950
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd safetyglide had a needle shielding failure.The following information 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".
Event or Problem Description
Imdrf codes must be updated.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: 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: 18692392
• Report Number: 1920898-2024-00051
• Device Sequence Number: 20938482
• Product Code: MEG
• UDI-Device Identifier: 30382903059509
• UDI-Public: (01)30382903059509
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305950
• Device Lot Number: 3198139
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown