MAUDE Adverse Event Report: BECTON DICKINSON; SET, INTRAVASCULAR, TUBING

Catalog Number 79591

Device Problem Material Puncture/Hole (1504)

Patient Problem Pain (1994)

Event Date 06/26/2019

Event Type  malfunction  

Event Description

After orthopedic surgery, the patient had pca morphine via alaris pump.During the night, the patient's pain increased despite pca administration.Rn then noticed the pca tubing was wet and discovered a crack in the tubing.The tubing was replaced and then pain became better controlled.

• Type of Device: SET, INTRAVASCULAR, TUBING
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 8887386
• MDR Text Key: 154113774
• Report Number: 8887386
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2019

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: No Information
• Device Catalogue Number: 79591
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4745 DA
• Patient Weight: 31