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

Catalog Number 305901

Device Problem Leak/Splash (1354)

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

Event Date 01/24/2024

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 leaked.The following information was provided by the initial reporter: "giving a rylaze injection and the needle leaked a small amount of medication when the plunger was pushed.Pt received majority of medication and pharmacy was consulted to see if any additional medication was needed.Pharmacy advised that the med received was sufficient for this dose.The needle seemed to be attached securely to the syringe.There was another nurse that said that this same thing happened to her recently." background: event date: 1/24/2024 ih #: (b)(4) mfg #: 305901 description: needle 25gax5/8 safety glide 305901 sample available : yes (if sample is available and would like it sent for your evaluation, please reply all and attach a return shipping label via email) lot #: 3306455 assessment: was there injury? no frontline caregivers contact information (if applicable): (b)(6) account (b)(6) recommendation/request: (b)(6) next steps: supplier¿s next steps: if you would like the product returned, please reply all with a return shipping label attached within 10 days that this email was sent ( on (b)(6)2024).If no label is received,¿ product will be discarded.Address for return label: (b)(6) hospital; attn: (b)(6).

• Brand Name: BD SAFETY-LOK
• 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: 18855109
• MDR Text Key: 337869239
• Report Number: 1213809-2024-00151
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903059011
• UDI-Public: (01)30382903059011
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 3306455
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1