SILVERSOAKER

Report

Report Number: 2026095-2010-00284
Event Type: Other
Date Received: November 22, 2010
Date of Event: October 24, 2010
Report Date: October 24, 2010
Manufacturer: I-FLOW CORPORATION
Product Code: BSO
PMA / PMN Number: K063530
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NO SAMPLE REC'D FOR EVAL AND INVESTIGATION. W/O THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. NO ADD'L INFO HAS BEEN PROVIDED, ALTHOUGH REQUESTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. THE BEST EVIDENCE INDICATES THAT THE CATHETER WAS PULLED UNTIL IT STRETCHED AND BROKE. THE DIRECTIONS FOR USE (DFU) (1306078, REV. D) PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN IN ORDER TO PREVENT OR DECREASE CATHETER BREAKS ENTITLED: "TIPS FOR PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM." (1303971, REV. B). IT IS WORTH NOTING THAT I-FLOW'S CATHETER'S ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO 10993-1 TISSUE COMPATIBILITY GUIDELINES FOR IMPLANTATION OF UP TO 30-DAYS; COMPLICATIONS MAY ARISE IF A CATHETER (OR PORTION THEREOF) IS LEFT IN THE BODY FOR LONGER THAN THIS PERIOD OF TIME. IF ADD'L INFO PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS REC'D, THE FILE WILL BE REOPENED.

Description of Event or Problem · 1

CATHETER BROKE DURING REMOVAL. CATHETER INSERTED ON (B)(6) 2010. PT FAMILY MEMBER ATTEMPTED TO REMOVE CATHETER ON (B)(6) 2010, BUT FOUND IT STRETCHING. SHE RETURNED TO THE PHYSICIAN FOR REMOVAL. THE CATHETER BROKE AS THE PHYSICIAN REMOVED. NO ADVERSE EVENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SILVERSOAKER	CATHETER	BSO	I-FLOW CORPORATION	PM012-A	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR