MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX SPORAMPULE BIOLOGICAL INDICATOR

Model Number SA-020

Device Problems Break (1069); Insufficient Information (3190)

Patient Problem Chemical Exposure (2570)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

A technician at the facility reported that while retrieving the sporampule biological indicator from the table top incubator the glass ampule exploded causing the liquid to splash into the technician's eyes.The technician immediately flushed both eyes with water.After flushing, the technician has not experienced any discomfort or irritation due to the exposure.It is unknown if any medical attention was sought.This event could potentially cause user injury or illness.There have been no other similar reports related to this product.This complaint will continue to be monitored in the medivators complaint handling system.Not in a condition for return/evaluation.

Event Description

The facility reported a technician removed a biological indicator (bi) from table top incubator and the biological indicator immediately exploded.The liquid from the bi splashed into the technician's eye(s), leading to potential for patient injury.

• Brand Name: SPORAMPULE BIOLOGICAL INDICATOR
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): SPSMEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX; 6789 west henrietta rd.; rush NY 14543
• Manufacturer (Section G): SPSMEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: sadie martin ; 6789 west henrietta rd.; rush, NY 14543 ; 5853590130
• MDR Report Key: 6526709
• MDR Text Key: 73849089
• Report Number: 1319130-2017-00001
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Risk Manager
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SA-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other