MULTI LUMEN CENTRAL VENOUS CATHERIZATION KIT N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-17 for MULTI LUMEN CENTRAL VENOUS CATHERIZATION KIT N/A manufactured by Arrow Flash Howes.

Event Text Entries

[2951] During insertion of subclavian catheter, patient expired. Autopsy showed two puncture woulds to the aortainvalid data - regarding single use labeling of device. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: device discarded - unable to follow-up. Certainty of device as cause of or contributor to event: maybe. Corrective actions: use of all similar devices stopped temporarily. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5030
• MDR Report Key: 5030
• Date Received: 1993-06-17
• Date of Report: 1993-05-26
• Date of Event: 1993-04-07
• Date Facility Aware: 1993-05-24
• Report Date: 1993-05-26
• Date Reported to Mfgr: 1993-05-26
• Date Added to Maude: 1993-06-22
• 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: MULTI LUMEN CENTRAL VENOUS CATHERIZATION KIT
• Generic Name: SUBCLAVIAN CATHETER
• Product Code: GBP
• Date Received: 1993-06-17
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4733
• Manufacturer: ARROW FLASH HOWES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-06-17