MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD IV TUBING; INTRAVASCULAR ADMINISTRATOR SET

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: 1 photo was returned by the customer.It was reported that iv tubing is bulging just below the blue connector that attaches to the iv pump.After examination of the photo, it was determined that a bulge can be seen in the tubing.The complaint can be verified.A device history record review could not be performed because a model or lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the root cause of this failure was not identified as no product was returned.Rationale: per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.

Event Description

It was reported that unspecified bd¿ iv tubing is bulging and ruptured.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported that iv tubing is bulging just below the blue connector that attaches to the iv pump.Per submitted product complaint form: "the iv tubing developed an aneurysm like bulb in the tubing just below the blue connector that attaches to the iv apump.In one case, a critical medication stopped infusing when the tubing burst.".

• Brand Name: UNSPECIFIED BD IV TUBING
• Type of Device: INTRAVASCULAR ADMINISTRATOR SET
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11088392
• MDR Text Key: 224398160
• Report Number: 2243072-2020-02176
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1