VACUTAINER UNKNOWN 6430

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-08 for VACUTAINER UNKNOWN 6430 manufactured by Becton Dickinson Vacutainer Systems.

Event Text Entries

[1633] An e. R. Nurse drew two blood cultures w/vacutainer in two plain red top tubes (10 ml). A 10cc syringe (becton dickinson vacutainer systems catalog #9604) with an 18 gauge needle (becton dickinson vacutainer systems catalog #5199) was used to withdraw first transfer. During second transfer, the glass tube shattered spraying blood on nurse's nose, mouth, eyes and face. The patient's blood was hiv+. Eyes were immediately washed with il of nss. Mouth rinsed and nurse gargled with one bottle of h202. Nurse took complete shower immediately after event. Hiv and hepatitis baseline tests were conducted on the nurseinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory 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 not used as labeled/indended. 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: device discarded, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4315
• MDR Report Key: 4315
• Date Received: 1992-10-08
• Date of Report: 1992-08-07
• Date of Event: 1992-06-20
• Date Facility Aware: 1992-06-20
• Report Date: 1992-08-07
• Date Reported to Mfgr: 1992-06-22
• Date Added to Maude: 1993-05-20
• 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: VACUTAINER
• Generic Name: BLOOD TUBE
• Product Code: GIO
• Date Received: 1992-10-08
• Model Number: UNKNOWN
• Catalog Number: 6430
• Lot Number: 2C717
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4041
• Manufacturer: BECTON DICKINSON VACUTAINER SYSTEMS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-10-08