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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER

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BD (SUZHOU) INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383083
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
Event Type  malfunction  
Manufacturer Narrative
"investigation summary: in response to the event reported a device history review was conducted for lot number 8107020. 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. A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications. Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint. ".
 
Event Description
It was reported that a intima-ii y 24gax0. 75in prn ec slm npvc experienced a loose tubing clamp during use. The following was reported by the initial reporter: " on (b)(6) 2021, the patient underwent pci in the catheterization room with a closed intravenous indwelling needle. After returning to the ward after surgery, the indwelling needle clamp was found to be unable to close the fluid, and the patient was immediately given the treatment of replacing the indwelling needle. ".
 
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Brand NameINTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12081466
MDR Text Key267125526
Report Number3006948883-2021-00715
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/16/2021
Device Catalogue Number383083
Device Lot Number8107020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2018
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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