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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM; CATHETER
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BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM; CATHETER Back to Search Results
Catalog Number 383012
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that intima-ii y 20gax1.16in prn/ec slm had foreign matter.The following information was provided by the initial reporter: when the closed vein indwelling needle was used in the puncture room of the first ct room , the new package of 20g indwelling needle no.383012 was opened, and multiple stains and rust were found on the needle hub and rubber plug.
 
Event Description
It was reported that intima-ii y 20gax1.16in prn/ec slm had foreign matter.The following information was provided by the initial reporter: when the closed vein indwelling needle was used in the puncture room of the first ct room , the new package of 20g indwelling needle no.383012 was opened, and multiple stains and rust were found on the needle hub and rubber plug.
 
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 h6: investigation summary a device history review was conducted for lot number 0267245.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.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.
 
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Brand Name
INTIMA-II Y 20GAX1.16IN PRN/EC SLM
Type of Device
CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key11335892
MDR Text Key238663344
Report Number3006948883-2021-00236
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 Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/27/2023
Device Catalogue Number383012
Device Lot Number0267245
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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