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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 383028
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 1020977. 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, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications. Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint. Bd will continue to monitor this issue and encourages you to submit your sample for review. Investigation conclusion: dhr review: the complaint gauge is 24g,assembly at auto line 3 in feb. 2021,packaging at cfs packing machine in feb. 2021, lot quantity is 186k. Review the in process test and outgoing test report for this lot product, all test results meet the product specifications, no abnormality for it. Reviewed the production record and machine troubleshooting records for this lot product, no abnormality, deviation or rework activities found. No actual sample and picture returned, the status of the needle through the catheter cannot be confirmed. After catheter adapter final assembly, the visual inspection system 100% tested. The zone5 visual inspection system is also validated, therefore, such damaged product can be detected and rejected during the manufacturing process. Checked the retention sample of this lot, no such defect was found. No same complaint was received from the complaint lot. Conclusion(s): as no defective sample returned, no abnormality found on process, and there was a visual system that could detect and eliminate such defect, the root cause of the needle through the catheter cannot be determined. It may be that the force in the process of transportation caused the needle to rollback. When the catheter was slightly bent, the needle was pushed forward by the force, resulting in the needle through the catheter. The factory will continue to monitor such defects.
 
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system experienced needle through catheter during catheter introduction. The following information was provided by the initial reporter: at 9 am on (b)(6) 2021, the patient was given an infusion with an indwelling needle. The indwelling needle was found to have penetrated the catheter after examination, and the indwelling needle was immediately replaced without adverse consequences to the patient.
 
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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 Key12169666
MDR Text Key263459508
Report Number1920898-2021-00756
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 06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383028
Device Lot Number1020977
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 Received06/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2021
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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