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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.16 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.16 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381334
Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problems Paralysis (1997); Device Embedded In Tissue or Plaque (3165)
Event Date 11/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). A sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. (b)(4).
 
Event Description
It was reported that a 20 g x 1. 16 in. Bd insyte-w¿ peripheral venous catheter broke off in use in a patient's right hand. The patient complained of paralysis in her hand and a "clack" in her vein. On (b)(6) 2016 the patient had surgery to remove the broken piece of catheter but the operation failed to remove it. No imaging studies were performed beforehand as the doctor ad surgeon were certain of the presence of the catheter in the patient.
 
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Brand Name20 G X 1.16 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6183315
MDR Text Key62679409
Report Number8041187-2016-00093
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 12/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381334
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/16/2016 Patient Sequence Number: 1
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