PORT A CATH HICKMAN 13.5F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-08 for PORT A CATH HICKMAN 13.5F manufactured by Davol.

Event Text Entries

[4928] The patient was sent to hospital from the doctor's office for retrieval of a portion of catheter in the patient's right atrium. The 18 cm. Portion of white double lumen catheter was safely removed in special procedures by the radiologist. The patient returned to the hospital the following day, 6/23/93 and on 6/24/93 had the port-a-cath and remaining portion of catheter safely removed. * #33 location of event: the exact location the patient was when the catheter separated is unknown. The catheter was retrived in radiology and the or. Invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, none or unknown, other, tubing. Conclusion: device failure directly caused event, none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7531
• MDR Report Key: 7531
• Date Received: 1994-01-08
• Date of Report: 1993-07-02
• Date of Event: 1993-06-22
• Date Facility Aware: 1993-06-22
• Report Date: 1993-07-02
• Date Reported to Mfgr: 1993-06-30
• Date Added to Maude: 1994-04-29
• 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: PORT A CATH HICKMAN 13.5F
• Generic Name: PORT-A-CATH FOR PLASMA PHORESIS
• Product Code: LKG
• Date Received: 1994-01-08
• Lot Number: 36 AD 1867
• Operator: OTHER
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 7210
• Manufacturer: DAVOL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-01-08