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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTERVASCULAR CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383083
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091)
Event Date 05/26/2019
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the intima-ii y 24gax0. 75in prn ec slm npvc was involved in a serious injury in the form of an infection. The device was embedded within the patient for four days. The patient experienced redness, swelling, and pain. Magnesium sulfate was applied. The device was removed, and two days afterwards pus had formed in the site the device had been placed in. The following information was provided by the initial reporter: the patient was given a venous indwelling needle on (b)(6) 2019. On (b)(6) 2019, the patient's infusion site showed redness and pain. The nurse pulled out the indwelling needle and let it wet and hot. On (b)(6) 2019, the swelling and pain were worse than before. The patient apply with wet and hot compress with magnesium sulfate. On (b)(6) 2019, the doctor punctured the part with a syringe needle, squeezed out the yellow pus, and made bacterial culture.
 
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Brand NameINTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
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 Key9250947
MDR Text Key178624592
Report Number3006948883-2019-00878
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/28/2021
Device Catalogue Number383083
Device Lot Number8043037
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 Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2018
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: 10/29/2019 Patient Sequence Number: 1
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