ON-Q SILVERSOAKER

Report

Report Number: 2026095-2008-00166
Event Type: Other
Date Received: October 2, 2008
Date of Event: September 3, 2008
Report Date: September 3, 2008
Manufacturer: I-FLOW CORP.
Product Code: MEB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS PROVIDED BY THE INITIAL REPORTER FROM THE PATIENT CHART. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT 752817, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. THE STERILITY INFORMATION FOR THIS LOT WAS IN THE FILE. A REVIEW OF THE LOT HISTORY FOUND NO OTHER COMPLAINTS FOR STERILITY ISSUES FOR THIS LOT. ALL I-FLOW PRODUCTS ARE STERILIZED AND SEALED IN APPROPRIATE PACKAGING, TO BE OPENED ONLY IN A STERILE ENVIRONMENT BY INDIVIDUALS TRAINED IN STERILE PROCEDURE. PRIOR TO RELEASE, ALL PRODUCTION LOTS ARE SUBJECTED TO STRINGENT LABORATORY TESTING TO ASSURE STERILITY. WITH THE ASSUMPTION THAT THE DEVICE WAS PROPERLY HANDLED BY THE CLINICAL PERSONNEL ASSOCIATED WITH THE SURGERY, THE DEVICE WAS INTRODUCED TO THE SURGICAL SITE IN A STERILE CONDITION. ANY INFECTION COMPLICATION FOLLOWING THEREAFTER IS MOST LIKELY DUE TO OTHER POSTOPERATIVE FACTORS. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL REOPEN THE COMPLAINT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ABSCESS FROM THE ON-Q PUMP. DATE OF SURGERY: 2008. DATE OF DIAGNOSIS: THE FOLLOWING MONTH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ON-Q SILVERSOAKER	INFUSION PUMP	MEB	I-FLOW CORP.	PM015-A	752817

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other