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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNSPECIFIED BD INTIMA II CATHETER INTERVASCULAR CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNSPECIFIED BD INTIMA II CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 10/17/2019
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the unspecified bd intima ii catheter was involved in an allergic reaction during use. After the patient was discharged, they experienced an abscess left at the puncture site. The abscess was disinfected and cleaned, and clean dressings were applied. After an examination four days later, pus was still found resulting in the patient being admitted for "abscess incision. " the following information was provided by the initial reporter: the patient was hospitalized on (b)(6) 2019. Due to neonatal hyperbilirubinemia, and he was discharged on october 16th for 4 days, during that time he was treated with blue light irradiation and indwelling needle infusion. On the second day after discharge, the parents carried the children to the ward, and the nurse found a small rice grain size abscess at the puncture site, and a centimeter of skin strip like redness along the direction of the blood vessels above the puncture site. The hydrocolloid dressing was applied for cleaning and disinfection, and the abscess at the puncture site was treated with dressing change with observing changes dynamically. Four days later, there was still pus, and the patient was admitted for abscess incision.
 
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Brand NameUNSPECIFIED BD INTIMA II CATHETER
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9540116
MDR Text Key182212704
Report Number3006948883-2019-01157
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/02/2020 Patient Sequence Number: 1
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