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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 26GAX0.56IN MZ SLM NPVC; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II 26GAX0.56IN MZ SLM NPVC; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383266
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2022
Event Type  malfunction  
Event Description
It was reported while using bd intima-ii 26gax0.56in mz slm npvc foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: in pediatrics, there is water drop in connector of the indwelling needle.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd intima-ii 26gax0.56in mz slm npvc foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: in pediatrics, there is water drop in connector of the indwelling needle.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 09-may-2022.H6: investigation summary: one defect sample was received by our quality team for evaluation.The sample returned was in an unopened package of lot 0140319.Fluid was observed inside the housing of the maxzero.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The fluid visible within the maxzero is consistent with the medical-grade silicone which is used as a lubricant in the maxzero products.The application of silicone is a closely regulated process and the weight of the silicone is checked at regular intervals during the manufacturing of the maxzero components.The evaluation of the biological and chemical data indicates that the component can be considered safe for clinical use.H3 other text : see h10.
 
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Brand Name
BD INTIMA-II 26GAX0.56IN MZ SLM NPVC
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14502638
MDR Text Key300442624
Report Number3014704491-2022-00200
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 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/18/2023
Device Catalogue Number383266
Device Lot Number0140319
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2020
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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