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U.S. Department of Health and Human Services

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

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BD (SUZHOU) BD INTIMA II¿ IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383423
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)
Event Date 12/27/2017
Event Type  Injury  
Manufacturer Narrative
Investigation results: representative samples provided by the customer. The failure mode could not be observed in the samples provided. The batch history record was reviewed; no abnormalities were noted. The representative samples passed bi aseptic testing. Other possible factors are: repeated infusion in a vein, causing the vascular wall to suffer from hyperplasia, hypertrophy, leading to phlebitis. A puncture through the vein of the patient that went undetected could result in the formation of a hematoma that can lead to local swelling and ultimately leading to phlebitis. Disinfection procedure was not adequate leading to the infection. Phlebitis can also be caused by an improper drug-ratio during infusion. Conclusion: bd could not find evidence linking the manufacture of this device to the reported failure mode. No additional corrective action is required at this time.
 
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
On the third day of infusion, it was reported that a nurse noticed an infant¿s puncture point had developed an infection with a bd intima ii¿ iv catheter. The nurse disinfected the infant¿s area of infection with iodine, treated the infant with medication. Surgical treatment was performed to pump out the purulent fluid. The infant was discharged from the hospital on (b)(6) 2018. No further updates have been reported regarding additional treatment or medical intervention.
 
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Brand NameBD INTIMA II¿ IV CATHETER
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
8015652845
MDR Report Key7213000
MDR Text Key255268698
Report Number3006948883-2017-00220
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K100775
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 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Catalogue Number383423
Device Lot Number6335465
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2016
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: 01/23/2018 Patient Sequence Number: 1
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