PH/BLOOD GAS ANALYZER 1306

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-21 for PH/BLOOD GAS ANALYZER 1306 manufactured by Instrumentation Laboratory.

Event Text Entries

[2847] Employee accidently stuck by a contaminated needle which is part of the machine. The technician was accidently crushed against the needle holder, that does not securely lock in place, with the back of his hand. The needle holder flipped and the technician was stuck by the needle that comes in contact with the blood sampleinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. 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. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4874
• MDR Report Key: 4874
• Date Received: 1992-07-21
• Date of Report: 1992-07-20
• Date of Event: 1991-03-06
• Report Date: 1992-07-20
• Date Added to Maude: 1993-06-10
• 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: PH/BLOOD GAS ANALYZER
• Product Code: CCC
• Date Received: 1992-07-21
• Model Number: 1306
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4580
• Manufacturer: INSTRUMENTATION LABORATORY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-21