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

Catalog Number 305901

Device Problem Leak/Splash (1354)

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

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd safety-lok had leakage at luer connection.The following information was provided by the initial reporter: "the needle was securely on the syringe, and the majority of the vaccine leaked out the connection between the two." we have received the below product problem report.Stevens ref#(b)(4) has been assigned to this issue.Upon completion, please provide a quality investigation letter detailing your findings.Please advise on next steps for quality investigation and customer resolution: product problem report product information product code: (b)(4).Product description: needle hypo 25 x 5/8in safety glide sub q bx/50 p42.Lot/serial #: (b)(6).Expiry date: 2028-01-31.Problem information the needle was securely on the syringe, and the majority of the vaccine leaked out the connection between the two.Occurrences: 1 each.Sample information incident samples: 1 each.Representative samples: 0.No adverse event reported.

• Brand Name: BD SAFETY-LOK
• Type of Device: SAFETYGLIDE NEEDLE
• 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: 18893771
• MDR Text Key: 337782367
• Report Number: 1213809-2024-00164
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903059011
• UDI-Public: (01)30382903059011
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305901
• Device Lot Number: 3034676
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1