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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 383085
Device Problem Product Quality Problem (1506)
Patient Problems Abscess (1690); Phlebitis (2004); Staphylococcus Aureus (2058)
Event Date 03/25/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd intima-ii¿ closed iv catheter system was used and resulted in staphylococcus aureus. Phlebitis occurred on 3 separate occasions. The following information was provided by the initial reporter: patient appeared abscess on the puncture site, then using pus to fungi culture, the result was staphylococcus aureus. There were 3 puncture site phlebitis in total. (b)(6): this is the first time that the hospital's neonatology department used the bd xiangma 24g short catheter straight indwelling needle, and the bd xiangma 24 straight indwelling needle has been used before, and this month has started three times since the use of the short catheter indwelling needle. There was an adverse event of abscess at the puncture point after the needle was pulled out (two of which occurred after discharge). The nurse also reported that the needle was more enlarged after the short catheter indwelling needle was used, which was inconsistent with the product characteristics of the indwelling needle itself, and since the use of this batch the incidence of posterior phlebitis of the short catheter is higher. The current department suspects that there is a problem with the quality of the indwelling needle. The hospital has arranged for the fungus culture of the pus of the child. The result is still to be investigated. An unopened return to hope factory in xiangma can eliminate product quality problems through product inspection and dispel customer concerns. The result is staphylococcus aureus.
 
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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 Key8499324
MDR Text Key141498096
Report Number3006948883-2019-00266
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,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/03/2020
Device Catalogue Number383085
Device Lot Number7178244
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 Received03/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2017
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: 04/10/2019 Patient Sequence Number: 1
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