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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 INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381812
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Sepsis (2067); Skin Discoloration (2074)
Event Date 08/25/2019
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that after use of the bd insyte¿ autoguard¿ shielded iv catheter, neonatal sepsis developed in , 36-week pre term male. Neonatologist is informed and orders to initiate oxacillin and soft tissue ultrasound. The following information was provided by the initial reporter, translated from spanish to english: nursing assistant reports on infectious process at the site of venipuncture in the upper left limb, erythema and blush are observed, however there are no changes at the hemodynamic level, a pediatrician on duty is notified, nursing management is given, it is related to a venipuncture device , intravenous catheter # 24. The incident was noticed during the use. There was a abscess in the arm of the patient caused probably by the catheter. The patient passed by a treatment to this infection. In turn neonatologist is informed who orders to initiate oxacillin and soft tissue ultrasound neonatal sepsis, suspected metabolic disease, 36-week pre term born: (b)(6) 2019 and that same day he entered the neonatal unit. Insertion: (b)(6) 2019; withdrawal: (b)(6) 2019 - epicutaneous catheter - upper left limb - administration of: intravenous fluids, vancomycin and meropenem. Insertion: (b)(6) 2019; withdrawal: (b)(6) 2019 - short peripheral catheter 24g - upper left limb - patient with laboratory order whereby nursing leaves catheter installed with venous connector and immobilized with adhesive tape (affix cloth). And on (b)(6) in the note of receipt of shift there is no description of signs of phlebitis or signs of infection, however, at 20:30 hrs there is a nursing note that describes the signs of infection at the site of puncture. In turn neonatologist is informed who orders to initiate oxacillin and soft tissue ultrasound taking attached to the report. Insertion: (b)(6) 2019; withdrawal: (b)(6) 2019 - short peripheral catheter 24g - upper left limb - blood culture and start of oxacillin. Insertion: (b)(6) 2019; withdrawal: (b)(6) 2019- short peripheral catheter 24g - upper left limb - oxacillin administration, without continuous liquids. Insertion: (b)(6) 2019 tn; to the present ((b)(6) 2019) - short peripheral catheter 24g - upper left limb - oxacillin administration, without continuous liquids. At the moment with extension, connected to infusion set and infusion pump turned off, no use of needle-free connector, the access is currently covered with adhesive tape (cloth fixomull). Patient currently without skin lesions due to previous punctures, additionally the nurse (late shift), who is currently assigned to this patient reports that since admission to the neonatal unit the patient has remained with a mottled skin appearance, which does not change with the administration of its antibiotic treatment and its saturation has remained above 90%.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ 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 Key9086570
MDR Text Key163605478
Report Number1710034-2019-01018
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number381812
Device Lot Number9037525
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 Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2019
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: 09/19/2019 Patient Sequence Number: 1
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