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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383033
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Purulent Discharge (1812); Erythema (1840); Itching Sensation (1943); Swelling (2091)
Event Date 05/28/2019
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 after the bd intima-ii¿ closed iv catheter system was used on a patient, the puncture site became red, swollen, and itchy. A cold compress was used to alleviate swelling, but two days later, the skin remained red and swollen, with discharge from the puncture site and high temperature readings. The needle site was wet compressed with a iodophor cotton ball, and the swollen skin was compressed with magnesium sulfate solution and a dexamethasone injection. Three days of anti-inflammatory treatment resulted in the redness and swelling subsiding. The following information was provided by the initial reporter, translated from chinese to english: "it was found puncture site red, swell and itchy, then removed the product. Cold compress was applied to the swelling area. On may 30, the skin was markedly reddened and swollen, the skin temperature was high, there were purulent secretions at the needle mouth. The purulent fluid was cleaned up, the needle site was wet compressed with iodophor cotton ball, the swollen skin was wet compressed with magnesium sulfate solution and dexamethasone injection. After three days of anti-inflammatory, dressing change and wet compress treatment, the patient's redness and swelling had subsided. ".
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8722926
MDR Text Key148799794
Report Number3006948883-2019-00482
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 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date10/06/2021
Device Catalogue Number383033
Device Lot Number8233371
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2018
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: 06/21/2019 Patient Sequence Number: 1
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