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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II 20GAX1.16IN PRN SLM CATHETER

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BD (SUZHOU) INTIMA-II 20GAX1.16IN PRN SLM CATHETER Back to Search Results
Catalog Number 383007
Device Problem Leak/Splash (1354)
Patient Problem Inflammation (1932)
Event Date 01/20/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 8141307. 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. Unfortunately a sample could not be obtained for evaluation and testing. Investigation conclusion: bd will continue to monitor this issue. Root cause description: 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 intima-ii 20gax1. 16in prn slm leaked during use. The following information was provided by the initial reporter: on january 20th, due to acute cholecystitis, the patient was given intravenous infusion with intravenous indwelling needle, and fluid leakage was found.
 
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Brand NameINTIMA-II 20GAX1.16IN PRN SLM
Type of DeviceCATHETER
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9812441
MDR Text Key188673008
Report Number3006948883-2020-00079
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/28/2021
Device Catalogue Number383007
Device Lot Number8141307
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 Received02/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/10/2020 Patient Sequence Number: 1
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