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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 W/PRN YEL 24GA X .75IN; INTRAVASCULAR CATHETER
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN; INTRAVASCULAR CATHETER Back to Search Results
Model Number 383312
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2022
Event Type  malfunction  
Event Description
It was reported that the bd saf-t-intima w/prn yel 24ga x.75in experienced the needle through catheter and leakage.The following information was provided by the initial reporter: when the head nurse of nephrology implanted the indwelling needle to the patient and withdrew the needle, she found that the needle tip leaked from the side of the catheter tube.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance, this lot was accepted.
 
Event Description
It was reported that the bd saf-t-intima w/prn yel 24ga x.75in experienced the needle through catheter and leakage.The following information was provided by the initial reporter: when the head nurse of nephrology implanted the indwelling needle to the patient and withdrew the needle, she found that the needle tip leaked from the side of the catheter tube.
 
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Brand Name
BD SAF-T-INTIMA W/PRN YEL 24GA X .75IN
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15225394
MDR Text Key305422495
Report Number9610847-2022-00303
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833123
UDI-Public30382903833123
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K923702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number383312
Device Catalogue Number383312
Device Lot Number1210972
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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