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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER
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BD (SUZHOU) BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383012
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2020
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.(b)(4).
 
Event Description
It was reported that 6 bd intima-ii¿ closed iv catheter systems experienced foreign matter contamination.The following information was provided by the initial reporter: from december 1st to december 11th, the nurse found flocculation near the front of the catheter tube before vein puncture to the patient.
 
Manufacturer Narrative
H.6.Investigation: a device history review was conducted for lot number 9077608.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, the affected device could not be returned; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to test the composition of the foreign materiel, our quality engineers were unable to determine the root cause for this complaint.
 
Event Description
It was reported that 6 bd intima-ii¿ closed iv catheter systems experienced foreign matter contamination.The following information was provided by the initial reporter: from december 1st to december 11th, the nurse found flocculation near the front of the catheter tube before vein puncture to the patient.
 
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Brand Name
BD INTIMA-II CLOSED IV CATHETER SYSTEM
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key11181227
MDR Text Key227810178
Report Number3006948883-2021-00106
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 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/13/2022
Device Catalogue Number383012
Device Lot Number9077608
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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