MAUDE Adverse Event Report: CAREFUSION 2200, INC PLEURX; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 50-7510

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2018

Event Type  malfunction  

Event Description

Product did not reach patient.Product opened by nurse.Drainage line and plunger found unattached from drainage bottle.Visual inspection of 2 more unopened drainage kits from same lot found.Drainage line unattached from drainage bottle on 2nd kit and, retaining clip unattached from drainage bottle on 3rd kit.

• Brand Name: PLEURX
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway dr; vernon hills IL 60061
• MDR Report Key: 7850219
• MDR Text Key: 119344515
• Report Number: 7850219
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 50-7510
• Device Catalogue Number: 50-7510
• Device Lot Number: 001233048
• 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: 08/22/2018
• Date Report to Manufacturer: 09/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1