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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 24 G X 0.75 IN. INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 24 G X 0.75 IN. INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383408
Device Problems Break (1069); Detachment Of Device Component (1104); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2016
Event Type  Injury  
Manufacturer Narrative
A sample is not available for evaluation, however the customer returned photos for analysis. A photo inspection revealed a broken catheter with a slight deformity at its tip. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6947150. A manufacturing review revealed no related issues during production. Although the photos confirmed the customer's indicated failure mode, without a sample an absolute root cause for this incident cannot be determined. Additionally, our quality engineer notes that the reported failure most likely was caused by the patient while dragging his/her hand on the bedding and knocking his/her hand against a table. (b)(4).
 
Event Description
It was reported that a bd intima-ii¿ closed iv catheter system 24 g x 0. 75 in. Broke off in use. During the patient's rest period the patient used his/her hand to drag the bedding and knocked his/her hand against a table. The nurse checked on the patient and observed the catheter broken with an obvious deformity at the catheter hub. The patient's family turned on the light but the catheter could not be found. The patient received an x-ray and a ct scan but the broken catheter was not detected.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 24 G X 0.75 IN.
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 Key6167259
MDR Text Key62185220
Report Number3006948883-2016-00033
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 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number383408
Device Lot Number6047150
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 Received11/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2016
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: 12/12/2016 Patient Sequence Number: 1
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