MAUDE Adverse Event Report: BECTON DICKINSON BD UNDEFINED INFUSION DISPOSABLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problem Material Deformation (2976)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that bd undefined infusion disposable silicone pump segment bulged.The following information was provided by the initial reporter: this patient was on a continuous amiodarone drip via the primary iv (intravenous) line.Staff noted that the iv (intravenous) tubing inside of the channel had bubbled into a large balloon.The iv (intravenous) tubing was removed and a new one set-up.

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 on22-jan-2024.Medwatch report is mw5150762.E1.Address information was not provided, therefore, xx was used as a place holder.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.

• Brand Name: BD UNDEFINED INFUSION DISPOSABLE
• 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: 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18817926
• MDR Text Key: 336678541
• Report Number: 2243072-2024-00238
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1