MAUDE Adverse Event Report: BECTON DICKINSON AS SYR PSD MICROBORE; INTRAVENOUS EXTENSION TUBING SET

Catalog Number 10014914

Device Problem Leak/Splash (1354)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

Material#: 10014914.It was reported by customer that leaking fluids.Upon infusion, rn noticed some leaking from gub connection between nad and pressure disc tubing.Verbatim#: rcc received a complaint via email.Email(s) attached please see the below cif / product complaint for item 10014914 on stocking po (b)(4).Please provide next steps on credit or return / credit.Record number : (b)(4).Initial reporter : (b)(6).Sales rep : (b)(6).Description as reported : leaking fluids.Upon infusion, rn noticed some leaking from gub connection between nad and pressure disc tubing.This is multiple items being reported as failed splitting cifs for each vendor - items are a pressure disc tubing, cardiac filter, microclave external reference number : (b)(4).Account number : (b)(6).Account name : (b)(6).Product code : al10014914.Additional information: what is the date of event? (b)(6) 2024.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.The event occurred while in use with patient but no serious injury or harm was done.Delay in care.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? yes, we have the item(s) ready to be returned for evaluation.(b)(6).

• Brand Name: AS SYR PSD MICROBORE
• Type of Device: INTRAVENOUS EXTENSION TUBING SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18969010
• MDR Text Key: 339332085
• Report Number: 9616066-2024-00460
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233906
• UDI-Public: (01)10885403233906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811885
• 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: 03/07/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 10014914
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1