MULTILUMEN CENTRAL VENOUS CATHETER WITH BLUE FLEX TIP UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-29 for MULTILUMEN CENTRAL VENOUS CATHETER WITH BLUE FLEX TIP UNKNOWN manufactured by Arrow-howes International Inc..

Event Text Entries

[2334] 0n 12/27/91 triple lumen catheter inserrted into right subclavian for long term venous access. Follow-up chest x-ray showed good position. On 1/15/92 patient was confused and restrained in bed for safety. When nurse checked patient, triple lumen catheter was found on floor. Patient had no bleeding or shortness of breath but upon examination of catheter it appeared 2-3 cm of tip not found. Physician examined. Chest x-ray showed questionable linear density overlying right side of heart; can't exclude retained portion of central catheter. Ct of chest done on 1/15/92 raises the possibility of central vein catheter in right ventricle. Echocardiogram done on 1/16/92 showed: 1. Apcial and posterior basal aneurysm with calcification and the presence of a clot. 2. Left ventricular dilatation and 3. No echocardiographic density noted on right side of heart which suggests embolus catheter. Cardiac status was observed. No problems related to possible retained catheter noted from 1/15/92 until transfer to greenery extended care facility in baltimore on 3/3/92. Staff did not keep patient removed portion of the catheter because patient had streptococcus infection. Device 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. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: patient's condition - predisposed event. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3439
• MDR Report Key: 3439
• Date Received: 1992-07-29
• Date of Report: 1992-07-01
• Date of Event: 1992-01-15
• Date Facility Aware: 1992-01-15
• Report Date: 1992-07-01
• Date Reported to FDA: 1992-07-01
• Date Reported to Mfgr: 1992-01-20
• Date Added to Maude: 1993-04-20
• 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: MULTILUMEN CENTRAL VENOUS CATHETER WITH BLUE FLEX TIP
• Generic Name: HEPARIN COATED MULTILUMEN CATHETER
• Product Code: GBP
• Date Received: 1992-07-29
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: AK 1-329-1
• ID Number: PRODUCT #AK15703-H
• Device Expiration Date: 1994-08-01
• Operator: OTHER CAREGIVERS
• Device Availability: N
• Device Age: 01-DEC-91
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 3199
• Manufacturer: ARROW-HOWES INTERNATIONAL INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-29