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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. SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383336
Device Problem Leak/Splash (1354)
Patient Problem Needle Stick/Puncture (2462)
Event Date 01/14/2021
Event Type  Injury  
Manufacturer Narrative
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 saf-t-intima w/y adapter pnk 20gax1. 0in needle went through the tubing and stuck the rn. The following information was provided by the initial reporter: material no. : 383336 batch no. : 0206479. It was reported that when placing pressure on pink area close to the needle. Needle poked through plastic and stuck the rn's thumb. Hi, we had an incident today and need to know direction the bd would like to go? i am thinking we will need to set up an in-service for the department. Today in gi lab one of my rn's sustained a significant exposure with the use of a bd saf-t-intima 20 ga needle. She accessed the vein, was securing the device in the vein by placing pressure on the pink area close to the needle (area we hold to insert the needle) and when she was pulling back on the area we use to pull out the needle the needle actually poked thru the plastic (right below the pink area she was holding to secure the iv in the pt) and she sustained a needle stick to her thumb. I have done all the appropriate associate health & wellness things but wanted to contact you because other staff in gi lab are saying this has happened to them. I do have the packaging from todays incident if you want it. Per customer response: was there medical intervention for the needle stick? the rn in gi lab was starting an iv for a gi procedure. What was the rn¿s outcome? the pt was tested and is negative. Rn will not need to be tested. Needle puncture is healing. You stated that the issue has occurred before, were the incidents reported to bd? the previous occurrences were not reported to bd as manager was not aware they had occurred. If not, can you please fill out the attached complaint form with the additional occurrences? if physical samples are available, please provide address they will be returning from. Na.
 
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Brand NameSAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN
Type of DeviceINTRAVASCULAR 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
8015296192
MDR Report Key11305784
MDR Text Key238680133
Report Number9610847-2021-00060
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383336
Device Lot Number0206479
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 Received02/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2020
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: 02/09/2021 Patient Sequence Number: 1
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