HICKMAN SUBCUTANEOUS PORT 60227 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-04-16 for HICKMAN SUBCUTANEOUS PORT 60227 N/A manufactured by Davol.

Event Text Entries

[228] This incident revolves around a 35 year old female with diagnosis of metastatic adenocarcinoma, with unknown primary site. In 9/91 she underwent placement of a port-a-cath. On 12/13/91 a port-a-cath study revealed a large thrombus at the catheter tip. On 2/24/92 another flow study revealed an apparent break in the subclavian catheterjust below the clavicle. On 2/26/92 the port and the proximal portion of the catheter were removed. The distal portion was in the region of superior vena cava and was not removed due to physcian decision that any benefits were out weighted by the risks, due to the limited life expectancy of this patient. The patient expired on 3/12/92 due to advanced malignancydevice not 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. 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: no. Corrective actions: use of all similar devices stopped temporarily. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number394
MDR Report Key394
Date Received1992-04-16
Date of Event1992-02-26
Date Reported to Mfgr1992-03-17
Date Added to Maude1992-04-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHICKMAN SUBCUTANEOUS PORT
Generic NamePORT-A-CATH
Product CodeLLD
Date Received1992-04-16
Model Number60227
Catalog NumberN/A
Lot Number36FB6496 OR 36GB7487
ID NumberN/A
OperatorOTHER
Device AvailabilityN
Device Age01-AUG-91
Implant FlagY
Device Sequence No1
Device Event Key388
ManufacturerDAVOL


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-04-16

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