PLEURX PERITONEAL CATHETER KIT 50-9000B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-09-09 for PLEURX PERITONEAL CATHETER KIT 50-9000B manufactured by Carefusion, Inc.

MAUDE Entry Details

• Report Number: 1625685-2019-00105
• MDR Report Key: 8974661
• Report Source: COMPANY REPRESENTATIVE,CONSUM
• Date Received: 2019-09-09
• Date of Report: 2019-09-30
• Date of Event: 2019-08-28
• Date Mfgr Received: 2019-09-26
• Device Manufacturer Date: 2019-06-04
• Date Added to Maude: 2019-09-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: BDX ANNA WEHRHEIM
• Manufacturer Street: 75 N. FAIRVIEW DRIVE
• Manufacturer City: VERNON HILLS IL 60061
• Manufacturer Country: US
• Manufacturer Postal: 60061
• Manufacturer Phone: 8015652341
• Manufacturer G1: CAREFUSION, INC
• Manufacturer Street: 400 EAST FOSTER RD
• Manufacturer City: MANNFORD OK 74044
• Manufacturer Country: US
• Manufacturer Postal Code: 74044
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PLEURX PERITONEAL CATHETER KIT
• Generic Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Product Code: PNG
• Date Received: 2019-09-09
• Catalog Number: 50-9000B
• Lot Number: 1305198
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CAREFUSION, INC
• Manufacturer Address: 400 EAST FOSTER RD MANNFORD OK 74044 US 74044

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-09-09