BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 FR DL POWERPICC UPFT WITH MI AND TLS

    MDR report key: 2192446 · Received July 27, 2011

    Report

    Report Number
    3006260740-2011-00260
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION AS THE SAMPLE REMAINS IN USE. AN LHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PT WAS STRESSED PRIOR TO THE PICC INSERTION AS HE JUST RECEIVED THE DIAGNOSIS OF HAVING LYMPHOMA. DURING THE PICC INSERTION I TRIED TO "READ" THE PT BUT HE JUST REMAINED QUIET WITH HIS EYES CLOSED. IMMEDIATELY AFTER THE INSERTION AND AFTER I FLUSHED THE LINE WITH SALINE BUT BEFORE I PUT THE DRESSING ON THE PICC THE PT EXPERIENCED THE FOLLOWING SYMPTOMS: NAUSEA, HEAD FLUSH, INCREASED HEART RATE AND PANIC FEELING. THIS PT WAS VERY NERVOUS ABOUT HAVING THE PICC INSERTED. HE EXPLAINED TO ME AFTER THE FACT THAT HE WAS AFRAID OF ME. THE SYMPTOMS LASTED ABOUT 30 MIN., THE PICC TIP WAS LOCATED JUST ABOVE THE RA/SVC JUNCTION. DRESSING WAS APPLIED, PT SAT UP IN BED, O2 WAS INCREASED, COLD WET CLOTH PLACED ON HEAD AND NECK. PULSE WAS 116, BP 156/89, TEMP 103. (B)(6) GAVE THE PT TYLENOL FOR THE FEVER. WITHIN 30 MIN. ALL SYMPTOMS RELATED TO THE PICC INSERTION WERE RESOLVED. THE PT WAS SHAKING FROM A FEVER PRIOR TO THE INSERTION AND PROBABLY SHOULD HAVE HAD THE TYLENOL PRIOR TO THE PICC INSERTION. ELEVATED PULSE, BP AND TEMP WERE PROBABLY DUE TO THE PT'S DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC UPFT WITH MI AND TLS LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention