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

Catalog Number 305916

Device Problem Leak/Splash (1354)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that the bd safetyglide needles leak.The following information was provided by the initial reporter: "we use this sub product for our flu vaccines, we have had a couple of instances where the fluid for the vaccine comes out when inserting it into the arm and drips down the arm.Witch means the person is not getting there full dose of the vaccine.This product is a sub product that we are using currently, we usually use the bd safety glide for our flu clinics.Is there any chance we will be getting this product back in the near future.".

Manufacturer Narrative

B.3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: BD SAFETYGLIDE
• Type of Device: 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: 18107976
• MDR Text Key: 328127614
• Report Number: 1213809-2023-01245
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903059165
• UDI-Public: (01)30382903059165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951254
• 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: 11/08/2023

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
• Device Operator: Other
• Device Catalogue Number: 305916
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1