Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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 CATHETER SYSTEM; INTRAVASCULAR CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Model Number 383323
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2022
Event Type  malfunction  
Event Description
It was reported that 52 bd saf-t-intima catheter systems experienced foreign matter contamination.The following information was provided by the initial reporter: the head nurse of the emergency department reported that when the product was opened for inspection, it was found that there was a jelly-like foreign body on the needle tip.
 
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
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-jan-2023.H6: investigation summary; bd received 1 sample and 3 photos submitted for evaluation.The reported issue of foreign matter was confirmed upon visual inspection of the samples.Visual examination showed that excess medical grade silicone from our lubrication process was found on the tip of the catheter.Since the production of this product has been moved, no further actions will be taken at this manufacturing facility.H3 other text : see h10.
 
Event Description
It was reported that 52 bd saf-t-intima catheter systems experienced foreign matter contamination.The following information was provided by the initial reporter: the head nurse of the emergency department reported that when the product was opened for inspection, it was found that there was a jelly-like foreign body on the needle tip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD SAF-T-INTIMA CATHETER 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 Key16109653
MDR Text Key308648608
Report Number9610847-2022-00513
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833239
UDI-Public30382903833239
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 02/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number383323
Device Catalogue Number383323
Device Lot Number1243089
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-