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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER PERIPHERAL INTRAVASCULAR CATHETER
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BD (SUZHOU) BD INTIMA II¿ IV CATHETER PERIPHERAL INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383083
Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2018
Event Type  malfunction  
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 bd intima ii¿ iv catheter, had leakage and gap at tubing at y connect during use. No serious injury or medical intervention reported.
 
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Brand NameBD INTIMA II¿ IV CATHETER
Type of DevicePERIPHERAL INTRAVASCULAR 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 Key7814684
MDR Text Key118402511
Report Number3006948883-2018-00153
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 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2021
Device Catalogue Number383083
Device Lot Number8043022
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 Received08/06/2018
Was Device Evaluated by Manufacturer? Yes
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: 08/24/2018 Patient Sequence Number: 1
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