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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383592
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/14/2017
Event Type  Injury  
Manufacturer Narrative
Bd received actual samples and representative samples from the customer facility for investigation. The actual sample received was inspected under microscope with 183x magnification, this help us to visualize correctly the broken area. Once the sample was inspected, it was observed that the damage had a triangle way in the part of the catheter broke near to the skin. Representative samples were taken in order to reproduce the failure mode mentioned per the customer. It was confirmed as a user related issue and not related to manufacturing process. It¿s important to mentioned that during the device placement the nurse did not follow up the right procedure. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure mode. During the sample evaluation it was confirmed that this defect can be caused during an incorrect technique of device placement, if the catheter is damaged or broken per the cannula we can observe the same failure mode in our manufacturing samples.
 
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 the catheter from a bd nexiva¿ diffusics¿ closed iv catheter system partially broke off in patients arm. Medical intervention required.
 
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Brand NameBD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7097262
MDR Text Key109975985
Report Number9610847-2017-00171
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Catalogue Number383592
Device Lot Number7241693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2017
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: 12/07/2017 Patient Sequence Number: 1
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