Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC; INTRAVASCULAR 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 (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383062
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2020
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.Fda device problem code: 1094, fda patient problem code: 2199.
 
Event Description
It was reported that 4 cases of intima-ii y 20gax1.16in prn ec slm npvc experienced kinking during use.The following was reported by the initial reporter: "on (b)(6) 2020, in the process of high pressure injection, the joint of y tube and white tube folded, resulting in the stop of the inspection of high pressure.There were 4 cases.The indwelling needle instruction was not applicable to the high-pressure resistance description of ct.".
 
Event Description
It was reported that 4 cases of intima-ii y 20gax1.16in prn ec slm npvc experienced kinking during use.The following was reported by the initial reporter: "on (b)(6) 2020, in the process of high pressure injection, the joint of y tube and white tube folded, resulting in the stop of the inspection of high pressure.There were 4 cases.The indwelling needle instruction was not applicable to the high-pressure resistance description of ct.".
 
Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 9262029.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 the provided photograph and description of the event, our engineers have determined the root cause to be related to the use of pressurized injection.The bd intima-ii is an infusion only device and is not rated for high pressure injections.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key11072124
MDR Text Key223616035
Report Number3006948883-2020-01044
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 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/17/2022
Device Catalogue Number383062
Device Lot Number9262029
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/28/2020
Initial Date FDA Received12/24/2020
Supplement Dates Manufacturer Received12/30/2020
Supplement Dates FDA Received01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-