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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) INTERVASCULAR 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) INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383328
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932)
Event Date 08/06/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that an unspecified number of bd saf-t-intima¿ safety system with removable prn 22 ga 0. 75 in (non-dehp) were involved with patients experiencing infection. Medical intervention was administered as a result. The following information was provided by the initial reporter: between august 2019 and now, 13 patients have been registered at the geriatrics unit in several different units for having presented inflammations (some of which were significant) at the puncture site of the subcutaneous device, sometimes associated with a local infectious problem, despite compliance with the institutional hygiene protocol in force (use of an alcoholic antiseptic on the skin before setting up the infusion, changing the device after a maximum of 96 hours) by personnel experienced in this type of procedure. For the other cases mentioned, as these were retrospectively reported cases, the batches were not listed at the time of the adverse event. Concerning the consequences on patients : 1 patient with hyperthermia due to infection at the subcutaneous infusion site (right thigh) with formation of a collection that required a blade incision and wicking. 1 patient who presented a collection of poor evolution at the sc puncture site on the abdomen: incision of the abscess that shows necrosis + antibiotic therapy + wicking. 1 patient with an abscess on the abdominal wall opposite the cs: antibiotic therapy + incision and drainage of the abscess + wicking. 1 patient with erythematous erythematous inflammatory oozing cupboard on the left flank: removal of the abscess roof for complete evacuation of the collection + antibiotic therapy + wicking.
 
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Brand NameBD SAF-T-INTIMA SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP)
Type of DeviceINTERVASCULAR CATHETER
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 Key10475304
MDR Text Key210211434
Report Number9610847-2020-00266
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
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 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number383328
Device Lot Number0036796
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 Received08/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2020
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: 08/31/2020 Patient Sequence Number: 1
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