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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER
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BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Model Number 383322
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
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 when using the bd saf-t-intima¿ iv catheter safety system the catheter was defective/damaged/deformed.The following information was provided by the initial reporter.The customer stated: "when preparing for intravenous indwelling needle puncture for the patient, the nurse opened the outer package and found the needle bulging out.The needle could not be used.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-20.H6: investigation summary bd received a sample submitted for evaluation.The reported issue was not confirmed upon inspection of the sample.Since the reported failure was not confirmed a root cause cannot be established.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported when using the bd saf-t-intima¿ iv catheter safety system the catheter was defective/damaged/deformed.The following information was provided by the initial reporter.The customer stated: "when preparing for intravenous indwelling needle puncture for the patient, the nurse opened the outer package and found the needle bulging out.The needle could not be used.".
 
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Brand Name
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12186016
MDR Text Key262195664
Report Number9610847-2021-00338
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833222
UDI-Public30382903833222
Combination Product (y/n)N
PMA/PMN Number
K923702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2023
Device Model Number383322
Device Catalogue Number383322
Device Lot Number9277328
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2021
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2019
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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