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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383083
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 01/08/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone#: (b)(6). (b(4). Investigation summary: no defective picture and sample was returned. The status and composition of the stains inside the indwelling needle's package cannot be confirmed. Checked the retained samples, no hairs were found in the indwelling needle package. Checked the batch record of this lot, no abnormalities were found on in-process inspection, fg inspection record. 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. Unfortunately, a sample could not be obtained for evaluation and testing. 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 the bd intima-ii¿ closed iv catheter system primary packaging was stained/discolored. The following information was provided by the initial reporter, translated from (b)(6) to english: "during checking before use on (b)(6) 2021, there were stains inside the indwelling needle's package".
 
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Brand NameBD INTIMA-II CLOSED IV CATHETER SYSTEM
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11382599
MDR Text Key243887152
Report Number3006948883-2021-00266
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 02/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383083
Device Lot Number9346131
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 Received02/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2019
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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