EPIDURAL CATHETER 4533E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-21 for EPIDURAL CATHETER 4533E manufactured by Baxter Pharmacel.

Event Text Entries

[3017] Patient was in active labor, anesthesiologist attempted to place an epidural catheter. He stated that the catheter "sheared" off leaving a portion in the patient. (verified by x-ray) he placed a second catheter without problems, however the user end of the catheter split making the catheter shorter but usable. Comment by doctor "this was a difficult epidural due to the weight of the patient and her inability to remain still". A neurology consultation was done. Apparently there is a known risk for this to occur and the catheter tip will not be removed unless it becomes symtomatic. The catheter was not savedinvalid 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. Imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no 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: 4876
• MDR Report Key: 4876
• Date Received: 1992-07-21
• Date of Report: 1992-04-23
• Date of Event: 1992-04-01
• Date Facility Aware: 1992-04-01
• Report Date: 1992-04-23
• Date Reported to Mfgr: 1992-04-23
• Date Added to Maude: 1993-06-10
• 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
• Product Code: LHY
• Date Received: 1992-07-21
• Catalog Number: 4533E
• Lot Number: K1 5258
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4582
• Manufacturer: BAXTER PHARMACEL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-21