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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¿ SHIELDED IV CATHETER INTRAVENOUS CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVENOUS CATHETER Back to Search Results
Catalog Number 381423
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2017
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. The initial reporter also notified the fda on (date) via medwatch # 5072257 19-sep-2017. Per medwatch report, device is available for evaluation; however, there is no customer contact information listed on the report.
 
Event Description
It was reported that the female patient was admitted to the emergency room (b)(6) 2017 at 1334. While obtaining a patent iv using the bd insyte¿ autoguard¿ shielded iv catheter the patient stated she felt a pop within the vein. While showering the patient reported a dislodged iv and the catheter was not found. (patient thought the catheter remained in the vein) the nurse notified the physician of the patients concerns. This mdr is reported as a serious injury however, no medical intervention was noted in this report.
 
Manufacturer Narrative
Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode. The root cause is indeterminate.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTRAVENOUS 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 Key6988085
MDR Text Key90589043
Report Number1710034-2017-00280
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952861
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 01/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number381423
Device Lot Number7089529
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 Received10/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2017
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: 10/30/2017 Patient Sequence Number: 1
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