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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 PLUS¿ IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II PLUS¿ IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383055
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
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 when using the bd intima ii plus¿ iv catheter there was foreign matter on device cannula/needle/catheter.The following information was provided by the initial reporter and translated to english.The customer stated: "the nurse used the closed indignant needle for infusion treatment.Infusion liquid and yellow stains were found in the indignant needle seat and extension tube.The device was replaced with a new one.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-29.H6: investigation summary: a device history review was conducted for lot number 0267298.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.Additionally, the affected sample was returned for evaluation and investigation purposes.Our engineers noted the presence of a yellow foreign material and sent the sample out for compositional testing.The reported non-conformance has been confirmed.Unfortunately, there was not a sufficient quantity of the foreign material present to obtain a positive identification of the material, and our engineers were unable to successfully match it to any other materials on the manufacturing floor.Without the ability to identify the material our engineers were not able to determine a root cause for this event.
 
Event Description
It was reported when using the bd intima ii plus¿ iv catheter there was foreign matter on device cannula/needle/catheter.The following information was provided by the initial reporter and translated to english.The customer stated: "the nurse used the closed indignant needle for infusion treatment.Infusion liquid and yellow stains were found in the indignant needle seat and extension tube.The device was replaced with a new one.".
 
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Brand Name
BD INTIMA II PLUS¿ IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH  215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH   215126
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12681157
MDR Text Key278146875
Report Number3014704491-2021-00214
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/02/2023
Device Catalogue Number383055
Device Lot Number0267298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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