FDA Adverse Event Injury Summary report: N

BARD

MDR report key: 2532461 · Received April 5, 2012

Report

Report Number
MW5024979
Event Type
Injury
Date Received
April 5, 2012
Date of Event
August 9, 2011
Report Date
April 5, 2012
Manufacturer
BARD MEDICAL DIVISION
Product Code
LJS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT TO RECEIVE ANTIBIOTICS FOR INFECTION VIA DUAL LUMEN BARD PICC FOR SEVERAL WEEKS. BOTH LUMENS OF THIS LINE BECAME OCCLUDED WITH BLOOD CLOT X 6 OVER A ONE MONTH PERIOD. THIS REQUIRED SKILLED NURSING INTERVENTION EACH TIME TO RESTORE PATENCY TO CONTINUE INTERMITTENT ANTIBIOTIC THERAPY. THE BARD PICC, LIKE SOME OTHER CATHETER DEVICES, HAS BUILT-IN EXTERNAL VALVES THAT ARE ADVERTISED TO PREVENT BLOOD REFLUX INTO THE CATHETER AND THEREBY ELIMINATE THE NEED FOR HEPARIN TO KEEP THE CATHETER LUMENS FREE OF BLOOD CLOTS. THESE TYPES OF DEVICES HAVE RECENTLY BEEN SHOWN TO ALLOW BLOOD REFLUX SECONDARY TO GRAVITY, I.E THE BLOOD WILL FALL INTO A CATHETER IF THE TIP IS NOT DIRECTED DOWNWARD. SEE LETTER TO DR (B)(6) OF FDA COMPLIANCE (B)(6) 2012 AND LETTER TO FDA (B)(6) 2011. ENCOUNTERING OCCLUDED LINES OF THE EXTERNAL-VALVE TYPE IS NOT UNUSUAL IN OUR PRACTICE, HOWEVER, THE HIGH FREQUENCY IN THIS PARTICULAR PT WAS TO BE EXPECTED AS THIS PT'S PREFERRED POSITION IN BED WAS HORIZONTAL RATHER THAN HEAD ELEVATED. THE LAW OF GRAVITY PREDICTED A HIGHER RATE OF OCCLUSION IN THIS PARTICULAR CATHETER. THIS PT REFUSED HEPARIN FLUSHES TO PREVENT FURTHER OCCLUSION EVENTS AS HE HAD BEEN TOLD HEPARIN WAS NOT NECESSARY. DATES OF USE: (B)(6) 2011. REASON FOR USE: INFECTED WOUNDS SECONDARY TO MVA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BARD 5F POWERPICC SOLO LJS BARD MEDICAL DIVISION UNK

Patients

Seq Age Sex Outcome Treatment
1 34 YR Disability NEUTRAL PRESSURE INJECTION CAPS, BRAND UNK.| SALINE FLUSH SOLUTIONS, BRAND UNK.