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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM CATHETER

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BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM CATHETER Back to Search Results
Catalog Number 383012
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 10/06/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: there was no sample or photo available to bd for evaluation. Therefore, bd was unable to perform a thorough investigation to verify the reported issue. The manufacturing facility has been notified of this incident and the findings. A review of the device history record was performed and no quality issues were found during production. Investigation conclusion: complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends. Root cause description: since, an investigation could not be performed bd was unable to determine a possible root cause. Rationale: no need for capa.
 
Event Description
It was reported that intima-ii y 20gax1. 16in prn/ec slm leaked. The following information was provided by the initial reporter: when disposable intravenous indwelling needle is used, it is found that the pvc bag is leaking, stop using it, and check the situation of other unused products. The same problem has not been found.
 
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Brand NameINTIMA-II Y 20GAX1.16IN 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 Key11152505
MDR Text Key226321195
Report Number3006948883-2021-00051
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
Report Date 01/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2021
Device Catalogue Number383012
Device Lot Number8262038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2018
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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