ARROW N/A UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-09 for ARROW N/A UNKNOWN manufactured by Arrow International, Inc..

Event Text Entries

[613] It was stated that "patient was confused prior to the event. He was sitting in a wheelchair, found to be short of breath, respirations 34 and labored. The blue port to the triple lumen catheter was on the floor. The lumen was clamped off; the patient was lifted into bed and placed on left side in trendelberg position. Oxygen was increased, abg's drawn and chest x-ray done. No physical complications apparent after this event. The hub became disconnected at the connection site (it did not appear to have been chewed) with smooth edges"device labeled for single use. Patient medical status prior to event: unknown. Invalid data - regarding 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. Invalid data - whether 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: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 33108-1992-00004
• MDR Report Key: 1498
• Date Received: 1992-09-09
• Date of Report: 1992-08-21
• Date of Event: 1992-07-21
• Date Facility Aware: 1992-07-21
• Report Date: 1992-08-21
• Date Reported to FDA: 1992-08-21
• Date Reported to Mfgr: 1992-08-21
• Date Added to Maude: 1992-10-16
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• 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
• Generic Name: TRIPLE LUMEN CATHETER
• Product Code: GBP
• Date Received: 1992-09-09
• Model Number: N/A
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1432
• Manufacturer: ARROW INTERNATIONAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-09-09