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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTIMA-II 20GAX1.16IN PRN SLM; INTRAVASCULAR CATHETER
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INTIMA-II 20GAX1.16IN PRN SLM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383007
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
Event Type  malfunction  
Manufacturer Narrative
Medical 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 intima-ii 20gax1.16in prn slm adapter had a molding defect on it.The following information was provided by the initial reporter, translated from chinese to english: "connection part between the hub and the prn was not flat".
 
Manufacturer Narrative
H6: investigation summary unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Additionally the photograph submitted by the facility has been reviewed by our team of quality engineers.Based on the provided image they have determined that the most likely root cause for this event is related to a misalignment of the luer and adapter during the automated installation of the prn.H3 other text : see h10.
 
Event Description
It was reported that the intima-ii 20gax1.16in prn slm adapter had a molding defect on it.The following information was provided by the initial reporter, translated from chinese to english: "connection part between the hub and the prn was not flat.".
 
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Brand Name
INTIMA-II 20GAX1.16IN PRN SLM
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12418286
MDR Text Key283102557
Report Number3014704491-2021-00118
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
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 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/08/2021
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 Sequence Number1
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