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 Number: 394
• MDR Report Key: 394
• Date Received: 1992-04-16
• Date of Event: 1992-02-26
• Date Reported to Mfgr: 1992-03-17
• Date Added to Maude: 1992-04-22
• 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: HICKMAN SUBCUTANEOUS PORT
• Generic Name: PORT-A-CATH
• Product Code: LLD
• Date Received: 1992-04-16
• Model Number: 60227
• Catalog Number: N/A
• Lot Number: 36FB6496 OR 36GB7487
• ID Number: N/A
• Operator: OTHER
• Device Availability: N
• Device Age: 01-AUG-91
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 388
• Manufacturer: DAVOL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-04-16