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U.S. Department of Health and Human Services

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

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382533
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Extravasation (1842); Pain (1994); Thrombus (2101)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter cannula separated from the hub after removing it from the patient during use, but was not noticed. The patient experienced pain in the arm for "several weeks" after the iv removal, and it was believed that the broken cannula had remained in the vein, requiring surgical intervention to remove it. However, additional information from the customer confirms that "there was no evidence of a catheter in the vein tissue", and the vein had a significant clot present, leading the physician to have believed that the "ridge" felt on the patient's forearm was the catheter, when it was "likely" the clot. The following information was provided by the initial reporter: "patient had a 20g 1 inch insyte iv catheter inserted. The iv became interstitial and the iv was removed. Nurse did not notice that the iv cannula had separated from the hub. The patient continued to have pain in his arm for several weeks and upon consultation with a physician it was identified the cannula was still in the vein. Patient required surgical intervention to removed the cannula. " "i have confirmed with our pathology lab that there was no evidence of a catheter in the vein tissue specimen retrieved at the time of surgery. Only one specimen retrieved so nothing identified. The vein was traumatized with a significant clot present which was quite firm, so to the surprise of everyone the ridge felt on the patient¿s forearm was likely that rigid clot. ".
 
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Brand NameBD 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
8015652341
MDR Report Key8857235
MDR Text Key153158081
Report Number1710034-2019-00841
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number382533
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
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: 08/02/2019 Patient Sequence Number: 1
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