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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 GA X 1.0 IN BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 GA X 1.0 IN BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382633
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/02/2016
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed. Udi #: (b)(4).
 
Event Description
It was reported that the tip of a 20 ga x 1. 0 in bd insyte¿ autoguard¿ bc shielded iv catheter broke off while in use. The patient received an x-ray of his/her elbow and a ct scan of his/her arm. The broken catheter was found in the patient's skin and the patient was evaluated by an interventional radiologist and an orthopedic md. There was no report of additional medical or surgical interventions.
 
Manufacturer Narrative
Results: although it was initially reported that a sample was available, a sample was not returned. However, the customer did provide a photo to be evaluated. A photo inspection revealed that the photo was too small to see any device details and enlarging the photo distorted the view. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6202506. 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.
 
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Brand Name20 GA X 1.0 IN BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV 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 INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6126446
MDR Text Key60845651
Report Number1710034-2016-00060
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Emergency Medical Technician
Device Expiration Date06/30/2019
Device Catalogue Number382633
Device Lot Number6202506
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 Received11/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2016
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: 11/23/2016 Patient Sequence Number: 1
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