CVP CATHETER 3 LUMEN 41401-04-01

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 CVP CATHETER 3 LUMEN 41401-04-01 manufactured by Abbott Laboratories.

Event Text Entries

[21045453] On 5/6/93, an abbott 3 lumen cvp catheter was placed in the left subclavian vein. Post placement chest x-ray that day showed tip of catheter in the upper superior vena cava with no evidence of pneumothorax. Chest x-ray and chest cat scan on 5/11/93 showed a pneumothorax on the left with a hydro pneumothorax present. Physician felt the pneumothorax was probably related to central line placement, however, it is also possible this is the second etiology. Chest tube inserted. Patient discharged 5/18/93. All abbott 3 lumen cvp catheters have been removed from inventory and another company's catheter purchaseddevice labeled for single use. Patient medical status prior to event: satisfactory 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: other. Results of evaluation: none or unknown, unanticipated adverse reaction - short term. Conclusion: device discarded - unable to follow-up. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device discarded, device permanently removed from service. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5026
• MDR Report Key: 5026
• Date Received: 1993-06-17
• Date of Event: 1993-05-11
• Date Facility Aware: 1993-05-11
• 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: CVP CATHETER 3 LUMEN
• Generic Name: CVP CATHETER
• Product Code: GBP
• Date Received: 1993-06-17
• Model Number: 41401-04-01
• Catalog Number: 41401-04-01
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4729
• Manufacturer: ABBOTT LABORATORIES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-06-17