V-CATH 690-50 4.5. FRENCH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-05 for V-CATH 690-50 4.5. FRENCH manufactured by Hdc Corporation.

Event Text Entries

[15742176] The dual lumen picc was placed in the patient's right arm on 2/6/93 with x-ray confirmed placement in the superior bena cava while he was in the st. Joseph's hospital. He went home on 2/18/93. On 3/3/93 the hospice nurse taking care of the patient called to say that one port of the picc line was leaking they could was the othner lumen for his continuious solutionmax infusion on an intelligent pump. They had been using the leaking lumen to give iv lasix with small syrings. Then on 3/10/93 the hospice nurse called again to say that the "v" connection of the picc line had cone off so they pulled the rest of the picc linedevice 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. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6116
• MDR Report Key: 6116
• Date Received: 1993-04-05
• Date of Report: 1993-03-12
• Date of Event: 1993-03-10
• Date Facility Aware: 1993-03-10
• Report Date: 1993-03-12
• Date Reported to FDA: 1993-03-12
• Date Reported to Mfgr: 1993-03-10
• Date Added to Maude: 1993-08-06
• 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: V-CATH
• Generic Name: DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER 4.5 FRENCH
• Product Code: GBP
• Date Received: 1993-04-05
• Catalog Number: 690-50 4.5. FRENCH
• Lot Number: 1004
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-FEB-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5806
• Manufacturer: HDC CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-04-05