UNKNOWN LPS 7513

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-13 for UNKNOWN LPS 7513 manufactured by Strato.

Event Text Entries

[3032] There was a crack in the lifeport catheter. There is extravasation in the flow of the contrast medium out of the catheter through a rent in the catheter. The lifeport was removed after the problem was confirmed by x-ray studies. The lifeport was not available for examination because the family asked for thre device. The physician complied wit the family's requestdevice labeled for single use. Patient medical status prior to event: fair 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. 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: unknown (cannot determine). Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5635
• MDR Report Key: 5635
• Date Received: 1993-07-13
• Date of Report: 1993-06-28
• Date of Event: 1993-05-28
• Date Facility Aware: 1993-05-28
• Report Date: 1993-06-28
• Date Reported to Mfgr: 1993-06-28
• Date Added to Maude: 1993-07-19
• 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

• Generic Name: LIFEPORT
• Product Code: LKG
• Date Received: 1993-07-13
• Model Number: UNKNOWN
• Catalog Number: LPS 7513
• Lot Number: 225201
• ID Number: UNKNOWN
• Operator: OTHER
• Device Availability: N
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 5334
• Manufacturer: STRATO

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-07-13