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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHT 360DEG TB 25CM INTRAVASCULAR ADMINISTRATION SET

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHT 360DEG TB 25CM INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 394926
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems Underdose (2542); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that connect a wht 360deg tb 25cm tubing ruptured. This occurred on 3 occasions. The following information was provided by the initial reporter: medication used with the product? omnipaque. Leakage? yes, large amount of contrast agent on patient, examination table and floor. Impact on a patient? contrast examination on ct - patient has had less contrast than necessary during the examination. Samples? unused sample can be sent for investigation. We have had the problem with some stopcocks. The tubing burst open during injection at the level of the stopcock.
 
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Brand NameCONNECTA WHT 360DEG TB 25CM
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11382512
MDR Text Key266420554
Report Number9610847-2021-00084
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394926
Device Lot Number0183678
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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