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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; INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Model Number 383312
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2022
Event Type  malfunction  
Event Description
It was reported that foreign matter was found on 5 bd saf-t-intima¿ iv catheter safety systems during use.The following information was provided by the initial reporter, translated from chinese: "when the head nurse of the respiratory department of the hospital performed indwelling needle puncture for the patient on (b)(6) 2022, foreign matter was found at the tip of the catheter tube when the needle core was adjusted after the package of the indwelling needle was opened".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that foreign matter was found on 5 bd saf-t-intima¿ iv catheter safety systems during use.The following information was provided by the initial reporter, translated from chinese: "when the head nurse of the respiratory department of the hospital performed indwelling needle puncture for the patient on june 2, 2022, foreign matter was found at the tip of the catheter tube when the needle core was adjusted after the package of the indwelling needle was opened".
 
Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of foreign matter 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.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
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Brand Name
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
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 Key14887620
MDR Text Key302341130
Report Number9610847-2022-00247
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833123
UDI-Public30382903833123
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K013800
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 07/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number1210971
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/06/2022
Initial Date FDA Received07/01/2022
Supplement Dates Manufacturer Received07/07/2022
Supplement Dates FDA Received08/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2021
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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