M.R.I. SUBCUTANEOUS PORT 0602680

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-02 for M.R.I. SUBCUTANEOUS PORT 0602680 manufactured by Bard Access Systems, Inc..

Event Text Entries

[19900567] On 5/6/93, 59 year old female had mediport inserted in left arm for adjuvant chemotherapy administration. Patient developed swelling in left arm and two days later, on 6/1/93, mediport was surgically removed. Mediport was sent to manufacturer for evaluation on 6/18/93. Report from manufacturer has not been received as of this date. Invalid 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. Invalid data - regarding whether event presents imminent hazard. 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: 9756
• MDR Report Key: 9756
• Date Received: 1993-08-02
• Date of Report: 1993-07-06
• Date of Event: 1993-05-06
• Report Date: 1993-07-06
• Date Added to Maude: 1995-01-20
• 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: M.R.I. SUBCUTANEOUS PORT
• Generic Name: MEDIPORT
• Product Code: LKG
• Date Received: 1993-08-02
• Model Number: 0602680
• Lot Number: 36DD2814
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 9408
• Manufacturer: BARD ACCESS SYSTEMS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1993-08-02