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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET

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CAREFUSION LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2000E CHINA
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/02/2020
Event Type  Malfunction  
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 ll vlv adpt (stand alone) was blocked during use. The following information was provided by the initial reporter: on (b)(6), when the picc outpatient department normally gave the patient the picc maintenance, the infusion connector did not flow the drug fluid, which affected the use of picc. The infusion connector was replaced and could be used normally afterwards.

 
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Brand NameLL VLV ADPT(STAND ALONE)
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 s state st
sandy UT 84070 3213
Manufacturer Contact
brett wilko
9450 s state st
sandy, UT 84070-3213
8015652341
MDR Report Key10216165
MDR Text Key202583804
Report Number9616066-2020-01938
Device Sequence Number1
Product Code FPA
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2020
Device MODEL Number2000E CHINA
Device Catalogue Number2000E CHINA
Device LOT Number17077698
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/25/2019
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: 06/30/2020 Patient Sequence Number: 1
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