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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 IV CATHETER SAFETY SYSTEM 22 G X 0.75 IN. INTERVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 22 G X 0.75 IN. INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383323
Device Problems Leak/Splash (1354); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the bd saf-t-intima iv catheter safety system 22 g x 0. 75 in. Experienced leakage during use. The following information was provided by the customer: material no. 383323, batch. Unknown (provided 8025673). It was reported the rubber stopper blew out of catheter and blood sprayed everywhere. We recently had a customer complain about product #383323. They said that the rubber stopper would blow out of the catheter, causing blood to spray out everywhere. The particular lot # is 8025673. They are returning their remaining case of that lot number to us. The initial reported from owens & minor called in a product complaint from one of their customers diagnostic x-ray and imaging. The affected product is 383323 lot 8025673. The end user stated the stopper blew out and sprayed blood. This was the 2nd incident they have had with this lot. They have 4 cases of the same lot.
 
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Brand NameBD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 22 G X 0.75 IN.
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8465238
MDR Text Key141064443
Report Number9610847-2019-00253
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 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383323
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/29/2019 Patient Sequence Number: 1
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