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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 INTRAVASCULAR CATHETER

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BD (SUZHOU) INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383019
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 10/31/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: in response to the event reported a device history review was conducted for lot number 0063911. 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. A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the units were found to be free of any debris or other abnormalities. Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
Event Description
It was reported that a intima-ii y 22gax1. 00in prn/ec slm had foreign matter before use. The following was reported by the initial reporter: "the patient was admitted to our hospital for emergency treatment due to excessive drinking, and the doctor ordered that compound sodium chloride 500m intravenous drip be given once a day. When three or eight pairs of closed venous indwelling needles were checked before infusion, foreign bodies were found on the soft wall of the closed venous indwelling needles. A new batch of closed venous indwelling needles was immediately replaced, and the infusion was successfully completed. It had no effect on the patients. ".
 
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Brand NameINTIMA-II Y 22GAX1.00IN PRN/EC SLM
Type of DeviceINTRAVASCULAR CATHETER
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 Key11003870
MDR Text Key227927167
Report Number3006948883-2020-00946
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 11/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383019
Device Lot Number0063911
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 Received11/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2020
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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