EPIDURAL CATHETER 477505

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-30 for EPIDURAL CATHETER 477505 manufactured by Abbott Labortories.

Event Text Entries

[2233] On 3/5/92, crna attempting epidural anesthesia for labor and deliveral patient. The cathter would not thread into the epidural spae. Crna said he felt like he hit bone so he began withdrawing the catheter and felt it snap. Crna then pulled the introducter with the catheter out and found it to be frayed at the distal end. X-rays revealed a tip sheared distal portion of the epidural catheter in the lumbr area. No preent actions are planned for the patientinvalid 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: 3909
• MDR Report Key: 3909
• Date Received: 1992-06-30
• Date of Report: 1992-06-30
• Date of Event: 1992-03-05
• Report Date: 1992-06-30
• 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: EPIDURAL CATHETER
• Generic Name: CONTINUOUS EPIDURAL
• Product Code: LHG
• Date Received: 1992-06-30
• Model Number: 477505
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 3649
• Manufacturer: ABBOTT LABORTORIES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-06-30