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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 383405
Device Problems Fluid Leak (1250); Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2017
Event Type  malfunction  
Manufacturer Narrative
Results: investigation summary: samples were returned and decontaminated for investigation. All samples and photos returned by the customer are for an intima ii 18g. The batch is 7019422, and there is blood on the end of the septum of the sample. Since the returned sample is similar to that of the photograph, this report only chooses representative samples and photos. The sample and the photo showed the reported defect. The septum from complaint/failed samples was inspected under 10x microscope. Observed that the hole was not fully closed after the needle was removed. Leak test was performed on 220 unused samples from the affected lot that were returned by the customer. Found 4 of the 220 samples with leakage when subjected to system pressure of 45psi which failed specification. Ten retained samples from the affected batch #7019422 were tested for leakage test to 45psi system pressure per product specification. No leakage was observed in retained samples. The septums were also inspected under 10x microscope and no abnormality was found. The affected products were sent to 89 distributors and 52 hospitals. Only 5 out of the 89 distributors have reported leakage to date. The time for the complaint product to be sent to the complaint area by the distributor is in july/august (summer peak season). A review of the device history record revealed no irregularities during the manufacture of the reported lot #7019422. Investigation conclusion: the affected products could have only been subjected to a higher temperature than usual during the hot summer. The factory is fully investigating such defects. Thorough investigation followed by corrective and preventative actions will be conducted and implemented in capa (b)(4). Bd was able to duplicate or confirm the customer¿s indicated failure mode. The product was within specification.
 
Event Description
It was reported that a nurse found blood leaking from the needle hole of the septum on a bd intima-ii¿ closed iv catheter system after venipuncture. There was no report of injury or medical intervention.
 
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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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7140686
MDR Text Key95831166
Report Number3006948883-2017-00183
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number383405
Device Lot Number7019422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2017 Patient Sequence Number: 1
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