• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 22G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II INTERVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 22G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383409
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2019
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.
 
Event Description
It was reported that the intima-ii catheter y 22ga x 0. 75 in experienced a breach in sterility which was noted prior to use. The following information was provided by the initial reporter: it's noticed that original labelling information was printed inside the interior package, and customer suppose it may lead to contaminant to the product defective product wasn't used.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name22G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8931822
MDR Text Key155847430
Report Number3006948883-2019-00696
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143610
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,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/17/2020
Device Catalogue Number383409
Device Lot Number7139341
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2017
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: 08/26/2019 Patient Sequence Number: 1
-
-