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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 INTERVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383078
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Inflammation (2443)
Event Date 08/25/2019
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 an serious injury / allergic reaction occurred with a bd intima-ii¿ closed iv catheter system. The following information was provided by the initial reporter (chinese translation), "at 16:00 on (b)(6) 2019, it was red and pain for the patient on the indwelling needle placing site of the back of the right hand. After the indwelling needle was pulled out, it was not relieved obviously after the wet compress of magnesium sulfate. After using the 'deshishu ¿' applied to the affected area, it was better than before, but the skin temperature was still slightly higher. On (b)(6) 2019, the patient was admitted to the hospital again. It was found that the left forearm had an induration of about 2*10 cm, and the skin was red and the skin temperature was high. The patient complained of pain, chills, chills, and fever. The left forearm was slightly relieved by the cold pack of the ice pack. ".
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR 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 Key9120269
MDR Text Key164021974
Report Number3006948883-2019-00806
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 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383078
Device Lot Number9023810
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 Received09/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2019
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: 09/25/2019 Patient Sequence Number: 1
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