LUMEN CUP CATHETER/SUB-CLAVIN CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-02 for LUMEN CUP CATHETER/SUB-CLAVIN CATHETER manufactured by Deseret Company.

Event Text Entries

[1313] Tip of cup catheter dislodged. M. D. Attempted to insert triple lumen cup catheter into (r) subclavin, when catheter was withdrawn it was noticed that the tip had been sheared off and remained in the patient. Patient was sent to the operating room to retreive tip. This was unsuccessful and patient was immediately transfereed to lenox hill hospital on 10/6/92 for admissioninvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated. Results of evaluation: other. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1660
• MDR Report Key: 1660
• Date Received: 1992-11-02
• Date of Report: 1992-10-20
• Date of Event: 1992-10-05
• Date Facility Aware: 1992-10-05
• Report Date: 1992-10-20
• Date Reported to FDA: 1992-10-20
• Date Reported to Mfgr: 1992-10-09
• Date Added to Maude: 1992-11-09
• 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: LUMEN CUP CATHETER/SUB-CLAVIN CATHETER
• Product Code: GBP
• Date Received: 1992-11-02
• Lot Number: M6TJ260
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1577
• Manufacturer: DESERET COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-11-02