FAST-CATH HEMOSTATIS INTRODUCER 406104 H68440610416

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-14 for FAST-CATH HEMOSTATIS INTRODUCER 406104 H68440610416 manufactured by Diag Corporation.

Event Text Entries

[20054812] Diag sheath 6f noted at side port when placed in patient. Sheath changed out in cath lab with no apparent injury to patient. Manufacturer rep. Called-lot replaced. On previous day additional sheath from same lot leaked. Patient required blood transfusion prior to proceeding with procedureinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3895
• MDR Report Key: 3895
• Date Received: 1992-07-14
• Date of Report: 1992-07-01
• Report Date: 1992-07-01
• Date Added to Maude: 1993-05-07
• 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: FAST-CATH HEMOSTATIS INTRODUCER
• Product Code: EYT
• Date Received: 1992-07-14
• Model Number: 406104
• Catalog Number: H68440610416
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 3635
• Manufacturer: DIAG CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-14