MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD SAFETYGLIDE; SAFETYGLIDE NEEDLES

Catalog Number 305916

Device Problem Leak/Splash (1354)

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

Event Date 02/13/2024

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 safetyglide leaked.The following information was provided by the initial reporter: "child was to be provided vaccines.When going to administer 1st vaccine (dtap), the needle and syringe with vaccine blew apart and sprayed onto writer.Child was poked at that time, but no vaccine administered.Child was then re-poked with new needle and new dose of vaccine in opposite arm, which was effective.Child's parents called to be notified of same." rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2024 site name/location: leduc public health centre level of harm: minimal harm ahs optional report to cmdsnet (health canada): incident details: child was to be provided vaccines.When going to administer 1st vaccine (dtap), the needle and syringe with vaccine blew apart and sprayed onto writer.Child was poked at that time, but no vaccine administered.Child was then re-poked with new needle and new dose of vaccine in opposite arm, which was effective.Child's parents called to be notified of same.Who was affected? patient frequency of problem: recurring.Device information device name/description: needle hypodermic safety 25ga x 1 in manufacturer: becton dickinson canada inc manufacturer code/model: 305916 serial or lot number: (b)(6) supplier: (b)(4) supplier catalogue number: 308-305916 was the device retained? no.

Manufacturer Narrative

Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

No additional information.

• Brand Name: BD SAFETYGLIDE
• Type of Device: SAFETYGLIDE NEEDLES
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas NJ 88780 ; MX 88780
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18865212
• MDR Text Key: 337769609
• Report Number: 2243072-2024-00262
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903059165
• UDI-Public: (01)30382903059165
• 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,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305916
• Device Lot Number: REGQ4069
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1