ARROW INTERNATIONAL, INC. UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-05 for ARROW INTERNATIONAL, INC. UNKNOWN manufactured by Arrow International, Inc..

Event Text Entries

[1065] Received order from physician to remove triple lumen catheter from right jugular. With patient sitting on side of bed, catheter was checked and determined to be intact; all ports were clamped. The catheter had been held secure by two sutures, which were released and area was cleansed with betadine. A 4x4 dressing was applied and taped securely. Soon after patient began eating his meal, began coughing, became short of breath and progressively went into cardiac arrest. He was immediately coded with all acls measures applied without success and was pronounced dead after being resuscitated for over an hourdevice 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, other, inherent risk of procedure, unanticipated. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: no. Corrective actions: device use continued with restrictions/limitations, user education provided. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2068
• MDR Report Key: 2068
• Date Received: 1993-01-05
• Date of Report: 1992-12-03
• Date of Event: 1992-10-20
• Date Facility Aware: 1992-10-20
• Report Date: 1992-12-03
• Date Reported to FDA: 1992-12-03
• Date Reported to Mfgr: 1992-12-03
• Date Added to Maude: 1993-01-08
• 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: ARROW INTERNATIONAL, INC.
• Generic Name: ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHERIZATION KIT
• Product Code: GBP
• Date Received: 1993-01-05
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: AK-35703B
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1914
• Manufacturer: ARROW INTERNATIONAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-01-05