FDA Adverse Event Injury Summary report: N

BARD 6.6 FR LOW-PROFILE SILICONE PORT

MDR report key: 1963769 · Received January 11, 2011

Report

Report Number
MW5019007
Event Type
Injury
Date Received
January 11, 2011
Date of Event
January 9, 2011
Report Date
January 11, 2011
Manufacturer
BARD
Product Code
LJT
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PER ADMITTING PHYSICIAN IN HISTORY AND PHYSICAL, "-- IS AN (B)(6) MALE WITH SEVERE '<1%' FACTOR VIII DEFICIENT HEMOPHILIA A WITH AN INHIBITOR OF 2.7 BU WHOSE PRIMARY CARE IS PROVIDED BY DR. (B)(6). HAD A PORT PLACEMENT ON (B)(6) 2010 AT (B)(6) HOSP IN CONJUNCTION WITH A CIRCUMCISION PROCEDURE. HE BEGAN PRIMARY PROPHYLAXIS ON (B)(6) 2010. AN INHIBITOR WAS FIRST NOTED BY LAB SURVEILLANCE ON (B)(6) 2010 AT 1.8 BU. IMMUNE TOLERANCE WITH ADVATE TO ERADICATE THE INHIBITOR WAS BEGUN ON (B)(6) 2010. HIS PEAK TITER RECORDED WAS 37 BU ON (B)(6) 2010. HIS LAST KNOWN INHIBITOR TITER WAS 2.7 BU ON (B)(6) 2010 DURING AN INTERCURRENT ILLNESS. HIS MOTHER REPORTS HIS PORT HAS HAD INCREASED RESISTANCE TO INFUSION AND SWELLING NOTED 3 DAYS AGO. THERE WAS NO UNDUE BLEEDING OR BRUISING AT THE PORT SITE. THE FAMILY CONTACTED THE (B)(4) OVERNIGHT TO REPORT PORT MALFUNCTION AND WERE DIRECTED TO (B)(6) ER IN (B)(6). CHEST X-RAYS DONE THERE SHOWED THE TUBING TO THE LEFT OF MIDLINE AND LOOPED ON ITSELF. CARE WAS TRANSFERRED TO (B)(6) HOSP, THE FAMILY DECLINED AMBULANCE TRANSFER AND ARRIVED BY PRIVATE CAR TO THE (B)(6) ER OVERNIGHT. AP AND LATERAL CXR REPEATED THIS AM SHOW HIS PORT TUBING LOOPED IN THE MAIN AND LEFT PULMONARY ARTERY."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BARD 6.6 FR LOW-PROFILE SILICONE PORT PORT LJT BARD RESB0700

Patients

Seq Age Sex Outcome Treatment
1 1 YR Hospitalization