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

Catalog Number	305945
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# 305945.Batch# 4005009b.It was reported that the bd safetyglide needle retracted prematurely.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Bd safetyglide 1ml syringe 27g x 1/2 (0.4mm x13mm) was used to administer heparin subcutaneously, as ordered.When going to inject patient while using this syringe, primary registered nurse (rn) noted the needle retracted into the syringe somehow upon needle contact with patient.Syringe/needle immediately removed from patient.Needle tip examined, and no signs of anything breaking off.Patient without any injury but had to be poked again with a new syringe/needle in order to receive medication.Ref: (b)(4).Lot #4005009b.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Imdrf codes update.
Event or Problem Description
Imdrf codes must be updated.

• 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: 20044783
• Report Number: 1920898-2024-00136
• Device Sequence Number: 15483248
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: (01)00382903059454
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: 4005009
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown