ARROW HOWES MULTILUMEN CENTRAL VENOUS CATHETERIZATION KIT AK14703

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-01 for ARROW HOWES MULTILUMEN CENTRAL VENOUS CATHETERIZATION KIT AK14703 manufactured by Arrow International.

Event Text Entries

[3045] Discovered by qa nurse during routine retrospective review. Patient with respiratory failure, probable pneumonia on top of chronic pulmonary fibrosis who was on ventilator. On 2/25/93, patient had evidence of mi per cardiacenzymes. Physician inserted left internal jugular triple lumen catheter at 10:44 a. M. Portable chest x-ray showed malposition of line with tip location indeterminate. After consultation with surgeon and cardiologist, catheter removed. Patient's bp dropped, cpr started immediately. Echo revealed fluid in chest. Left-chest tube inserted small amount of blood and air obtained. Patient pronounced at 11:35 a. M. Diagnosed as tension pneumothorax. Swan ganz catheter placed at 10:45 a. M. And was noted to be in good position on x-raydevice labeled for single use. Patient medical status prior to event: critical 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. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5774
• MDR Report Key: 5774
• Date Received: 1993-07-01
• Date of Report: 1993-06-04
• Date of Event: 1993-02-25
• Date Facility Aware: 1993-05-25
• Report Date: 1993-06-04
• Date Reported to FDA: 1993-06-04
• Date Reported to Mfgr: 1993-06-04
• Date Added to Maude: 1993-07-27
• 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: ARROW HOWES MULTILUMEN CENTRAL VENOUS CATHETERIZATION KIT
• Product Code: GBP
• Date Received: 1993-07-01
• Catalog Number: AK14703
• Lot Number: UNAVAILABLE
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5473
• Manufacturer: ARROW INTERNATIONAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-07-01