CV CATH 9.5 FR WITH GROSHONG VALUE AND VITA CUFF ANTIMICROBA DOUBLE LUMEN PERCUTANEOUS CATH 7726952

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for CV CATH 9.5 FR WITH GROSHONG VALUE AND VITA CUFF ANTIMICROBA DOUBLE LUMEN PERCUTANEOUS CATH 7726952 manufactured by Daval Inc..

Event Text Entries

[1991] On 2/2/92 during flushing of the catheter with normal saline after infusion of chemotherapy the flush leaked around the hub. The hub was tightened and flushing continued utilizing a 10cc syring with a 20ga needle. During flushing the hub of the proximal line of the groshong catheter broke off the needle shaft examination of the device revealed it to be clean break of the metal needle device at the junction with the winged plastic hub. Catheter immediately repaired by surgeon. Device labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure, telemetry failure, unanticipated adverse reaction - short term, hub. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4308
• MDR Report Key: 4308
• Date Received: 1992-07-31
• Date of Report: 1992-02-14
• Date of Event: 1992-02-02
• Date Facility Aware: 1992-02-02
• Report Date: 1992-02-14
• Date Reported to Mfgr: 1992-02-13
• Date Added to Maude: 1993-05-20
• 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: 0
• Initial Report to FDA: 0
• 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: CV CATH 9.5 FR WITH GROSHONG VALUE AND VITA CUFF ANTIMICROBA
• Generic Name: LONG TERM DUAL LUMEN PERCUTANEOUS CATHETER
• Product Code: FGH
• Date Received: 1992-07-31
• Model Number: DOUBLE LUMEN PERCUTANEOUS CATH
• Catalog Number: 7726952
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4034
• Manufacturer: DAVAL INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-31