MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO POLYURETHANE 3.5 FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461355

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Event Description

Infant being placed back in isolette after doing skin to skin with mother.Upon placing infant on mattress, purple capped tip of 3.5 fr nasogastric (ng) tube separated off of tube.Ng tube promptly removed and replaced.Original package was discarded.The identifying numbers, etc., were pulled from what was in the stock for that unit.No harm to the patient.

• Brand Name: KANGAROO POLYURETHANE 3.5 FR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9503139
• MDR Text Key: 172223085
• Report Number: 9503139
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461355
• Device Catalogue Number: 461355
• Device Lot Number: 1900925964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 DA