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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER
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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383083
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
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.(b)(4).
 
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system experienced foreign matter in the fluid path.The following information was provided by the initial reporter: before the infusion, the nurse opened the package and found yellow material at the connecting hub of the indwelling needle's catheter tube.The nurse replaced the indwelling needle for operation.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-05.Investigation summary a device history review was conducted for lot number 9346131.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.Additionally, composition testing was performed on the returned sample, allowing our engineers to positively associate it with the manufacturing process.Based on their review the most likely source of this material is residue from the injection molding process.H3 other text : see h10.
 
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system experienced foreign matter in the fluid path.The following information was provided by the initial reporter: before the infusion, the nurse opened the package and found yellow material at the connecting hub of the indwelling needle's catheter tube.The nurse replaced the indwelling needle for operation.
 
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Brand Name
BD INTIMA-II CLOSED IV CATHETER SYSTEM
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH 
MDR Report Key11388550
MDR Text Key242708270
Report Number3006948883-2021-00269
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 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/21/2022
Device Catalogue Number383083
Device Lot Number9346131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2021
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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