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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 GAUGE IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 GAUGE IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problems Entrapment of Device (1212); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/27/2022
Event Type  malfunction  
Event Description
Peripheral 20 gauge in left antecubital area iv was a hep lock and was found to be occluded.Attempt to flush w/o success and iv removed.Upon removal it was noted that only the hub was present and that the catheter was not attached.Imaging revealed subtle linear density favored to be within the left lower lobe pulmonary artery suspicious for small bore catheter fragment.Pt was taken to interventional radiology for removal; however, further imaging was not able to identify the fragment and no procedure was performed.Fda safety report id # (b)(4).
 
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Brand Name
20 GAUGE IV CATHETER
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
MDR Report Key13660903
MDR Text Key286594442
Report NumberMW5107866
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age29 YR
Patient SexMale
Patient Weight125 KG
Patient RaceBlack Or African American
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