MAUDE Adverse Event Report: BECTON DICKINSON UNDISCLOSED BD SMARTSITE EXTENSION SET ¿; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Defective Component (2292)

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

Event Date 01/06/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E4.The initial reporter also notified the fda on jan 2024.Medwatch report is (b)(4).In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.

Event Description

It was reported that bd undisclosed bd smartsite extension set, 1.2 micron low protein binding filter was damaged and leaked.The following information was provided by the initial reporter: blood found to be backing up in central line tubing.Upon further inspection, tpn was leaking out of filter.Filter removed and replaced in sterile fashion with two nurses.While replacing filter, the tubing connected to the filter completely cracked off.

Manufacturer Narrative

It was reported by customer that the tubing connected to the filter completely cracked off.One sample of material number 2426-0007 was submitted for quality investigation.Visual examination of the sample indicates that the infusion set was broken at the filter inlet port.Further investigation under magnification shows that a large force was applied on the filter port that caused it to break off.The white color of the polyethylene filter body indicates a force greater than the yield stress of the polyethylene was applied causing it to break.The customers complaint of component damage - leak was verified.Further examination of the break in the filter indicates that a large force was applied to the inlet port due to the white stress marks at the filter port break location.The root cause of the issue cannot be fully determined based on the description of the discovery of the filter break.It cannot be determined if the product failed before the nurses replaced the infusion set or during the act of replacement.The customer reported the material number and lot number as unknown.The following investigation was conducted using a possible material number and lot number match when back tracing the smartsite id numbers in the full assembly of the infusion set.A device history record review for model 2426-0007 lot number 23099360 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25aug2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

Material #: 2426-0007.Batch#: unknown.It was reported by customer that the blood found to be backing up in central line tubing.Upon further inspection, tpn was leaking out of filter.Filter removed and replaced in sterile fashion with two nurses.While replacing filter, the tubing connected to the filter completely cracked off.Verbatim: rcc received a complaint via email.Email(s) attached.Blood found to be backing up in central line tubing.Upon further inspection, tpn was leaking out of filter.Filter removed and replaced in sterile fashion with two nurses.While replacing filter, the tubing connected to the filter completely cracked off.Follow-up, customer response.None of the packaging from the broken filter was saved, however, i do have the actual broken filter that i can send back.If you would like me to send back, please send me a shipping label.

• Brand Name: UNDISCLOSED BD SMARTSITE EXTENSION SET ¿
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18779159
• MDR Text Key: 337085077
• Report Number: 2243072-2024-00206
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/26/2024
• 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