HAKIM BACTISEAL 82-3072 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-10 for HAKIM BACTISEAL 82-3072 * manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[19204643] Patient is a toddler. Shunt was placed approximately 2. 5 years ago for hydrocephalus. Patient was noted to have pooling of subcutaneous fluid around the shunt components. A shunt survey was done and showed a disconnection just at the bottom side of her valve. Csf was found to be freely coming from the distal valve. The original connection of the distal catheter to the valve was still intact with the suture in place, but the catheter had ruptured just 0. 5 cm below this. A new bactiseal peritoneal tubing was pulled into place. The old peritoneal catheter was then removed and was sent for pathologic evaluation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2123435
• MDR Report Key: 2123435
• Date Received: 2011-06-10
• Date of Report: 2011-06-10
• Date of Event: 2011-05-27
• Report Date: 2011-06-10
• Date Reported to FDA: 2011-06-10
• Date Added to Maude: 2011-06-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HAKIM BACTISEAL
• Generic Name: CATHETER, VENTRICULAR
• Product Code: HCA
• Date Received: 2011-06-10
• Model Number: 82-3072
• Catalog Number: *
• Lot Number: CJCBK6
• ID Number: *
• Device Availability: Y
• Device Age: 3 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CODMAN & SHURTLEFF, INC.
• Manufacturer Address: 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2011-06-10