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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 0142075
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/24/2021
Event Type  malfunction  
Event Description
Bd powerloc¿ max power-injectable infusion set without y-injection site, 20 gauge x. 75 in. ; the tubing crack and patient bled out and lost some medication at well. Was another needle/access required? yes. Did the patient have any symptoms due to the break/leak, i. E. Blood loss, labs drawn, etc. ? minimal blood loss possibly 15 ml. Was there additional treatments required due to product failure, i. E. Transfusion, etc. ? no. What was infusing at the time of the product failure? was it the micafungin? maintenance fluids and micafungin. Patient lost about 4 ml of the med, md was notified and ok with the lost amount. Was there a possibility or signs/symptoms of infiltration at the port site? yes, but only upon re-access. Did the volume of the leak cause the medication to be re-dosed by pharmacy? no. How was the spill/leak contained and handled? health care providers clamped his tubing and managed to flush some heparin into the port by pinching the leaking area before de-accessing. Was there a line-guard in place securing the tubing below the dressing , prior to the product failure? yes. Did this event occur when the patient was sedentary or mobile? patient was actively playing in bed with mom. What was the age of this patient? (b)(6) months old.
 
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Brand NamePORT ACCESS NEEDLE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key12922836
MDR Text Key281660261
Report Number12922836
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number0142075
Device Catalogue Number0142075
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2021
Event Location Hospital
Date Report to Manufacturer12/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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