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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 22GAX1.00IN PRN/EC SLM CATHETER

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BD (SUZHOU) INTIMA-II Y 22GAX1.00IN PRN/EC SLM CATHETER Back to Search Results
Catalog Number 383019
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 11/30/2020
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: (b)(4). Fda patient problem code: (b)(4).
 
Event Description
It was reported that intima-ii y 22gax1. 00in prn/ec slm tubing was damaged. The following information was provided by the initial reporter: when used the indwelling needle to infusion, it was found that the catheter tubing of indwelling needle. Removed it and press to stop bleeding. ************************************************************* 2020-12-15 received an update from the sales representative, the description of the incident was updated as follows: the sample has been retrieved. The patient may break due to pulling factors when going out. The indwelling needle extension tube is broken and blood leakage occurs, which does not lead to the patient's blood transfusion treatment. The patient's mood is normal, and the indwelling needle will be refilled. No blood exposure to the operator.
 
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Brand NameINTIMA-II Y 22GAX1.00IN PRN/EC 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
8015296192
MDR Report Key11131817
MDR Text Key225570976
Report Number3006948883-2021-00033
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383019
Device Lot Number0231195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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