MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK; SAFETYGLIDE NEEDLES

Catalog Number	305902
Medical Device Problem Code	Separation Problem (4043)
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
Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.
Event or Problem Description
Material: 305902.Batch#: 3312251.It was reported by the customer that administering flu vaccine to patient.After pushing plunger down and pulled back, the needle was disconnected from plunger and in patient¿s leg.Medical assistant (ma) pulled needle out of leg using a gloved hand.Verbatim: rcc received a complaint via email.Email(s) attached.Administering flu vaccine to patient.After pushing plunger down and pulled back, the needle was disconnected from plunger and in patient¿s leg.Medical assistant (ma) pulled needle out of leg using a gloved hand.Model# 305902; lot# 3312251.Customer response: can you share any physical sample or photo if available for investigation? not available: discarded.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.None.Could you please confirm is there any leak.Unknown.
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
Material: 305902, batch#: 3312251.It was reported that the bd safety-lok needle pulled out of the hub.The following information was provided by the initial reporter: "administering flu vaccine to patient.After pushing plunger down and pulled back, the needle was disconnected from plunger and in patient¿s leg.Medical assistant (ma) pulled needle out of leg using a gloved hand.".Model# 305902.Lot# 3312251.

• Brand Name: BD SAFETY-LOK
• Common Device Name: SAFETYGLIDE NEEDLES
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19554780
• Report Number: 1213809-2024-00380
• Device Sequence Number: 12464060
• Product Code: FMI
• UDI-Device Identifier: 30382903059028
• UDI-Public: (01)30382903059028
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 06/20/2024

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: 305902
• Device Lot Number: 3312251
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown