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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383012
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 04/22/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone number: (b)(6). Investigation summary: in response to the event reported a device history review was conducted for lot number 0168635. 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. Based on description of the event, our engineers were able to determine that the most likely root cause for this event is the forcing of fluid through the device during injection. The bd pegasus is an infusion only device and is not rated for high pressure injections. Bd will continue to track and trend for this issue.
 
Event Description
It was reported that 3 bd intima ii¿ iv catheter prn adapters leaked. The following information was provided by the initial reporter: "on (b)(6) 2021, the patient underwent thoracic aortography in the ct room. During infusion of fluid from the closed venous indwelling needle, the white plug at the indwelling needle head retreated. After infusion of fluid, the fluid and blood drained together. ".
 
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Brand NameBD INTIMA II¿ IV CATHETER PRN ADAPTER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
MDR Report Key12701235
MDR Text Key278574674
Report Number3014704491-2021-00224
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
Report Date 10/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383012
Device Lot Number0168635
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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