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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. INTRAVENOUS CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 24 G X 0.75 IN. INTRAVENOUS CATHETER Back to Search Results
Catalog Number 383408
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2017
Event Type  malfunction  
Manufacturer Narrative
Date received by manufacturer: 08/27/2017.
 
Manufacturer Narrative
The customer returned one sample. According to the representative, before use the product was intact and used on customer. The customer left the hospital. The second infusion day, nurse removed the needle of injection system from prn of intima ii after infusion. She found the rubber of prn with needle separated from prn. The customer couldn't confirm whether the product has been bumped during the time between insertion and second day infusion. Bd was able to duplicate and confirm the customers indicated failure mode. There is no related investigation on this same lot #. Product within specification. Capa not necessary.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that during use on the second infusion day, the nurse removed the needle of injection system from the bd intima-ii¿ closed iv catheter system 24 g x 0. 75 and found the rubber of prn (with needle) separated from prn. There was no report of injury or medical interventions.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 24 G X 0.75 IN.
Type of DeviceINTRAVENOUS 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 Key6886754
MDR Text Key246687735
Report Number3006948883-2017-00060
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,Followup,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number383408
Device Lot Number7075369
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2017
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: 09/22/2017 Patient Sequence Number: 1
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