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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. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP) CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP) CATHETER Back to Search Results
Catalog Number 383328
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Inflammation (1932)
Event Date 03/11/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Additional device lot #: 9057767; additional device expiration date: 2023-02-28. Additional device manufacture date: 2019-03-15.
 
Event Description
It was reported that bd saf-t-intima¿ safety system with removable prn 22 ga 0. 75 in (non-dehp). The following information was provided by the initial reporter: "over a period of 5-6 weeks, 3 patients developed severe inflammation at the puncture site (inflammation, induration, redness). One patient even had an abscess that had to be evacuated quickly. These catheters have been used for several years, the antisepsis protocol seems to have been respected, as well as the duration of insertion. Patient's current condition: excessive redness necessitated emergency surgical evacuation for one of the three patients. Actions taken: alcohol-based dressing for the 3 patients to reduce inflammation. Devices not kept. ".
 
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Brand NameBD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP)
Type of DeviceCATHETER
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9907968
MDR Text Key190979855
Report Number9610847-2020-00116
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
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 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383328
Device Lot Number9119696
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2019
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: 03/31/2020 Patient Sequence Number: 1
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