MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE; SYRINGE, ANTISTICK

Catalog Number	305945
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd safetyglide safety mechanism broke.The following information was provided by the initial reporter: "the entire safety device slide up and off the syringe when the nurse deployed it.I wanted to bring it to your attention in case there has been any other incidents.Staff may not report it if it occurs when there is no negative consequence.The rn discarded it but showed the charge nurse prior to doing so.Charge nurse verified her account.".
Additional Manufacturer Narrative
H.3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: one photo was received verifying the customer's complaint of safety mechanism breaking off.The photo clearly presents the issue at hand but without further information like a physical sample for further investigation, the root cause remains unknown.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Photo received.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: SYRINGE, ANTISTICK
• 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: 18671080
• Report Number: 1920898-2024-00043
• Device Sequence Number: 7194770
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: (01)30382903059455
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 305945
• Device Lot Number: 3255371M
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown