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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 INTRAVASCULAR CATHETER Back to Search Results
Model Number 382623
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device brand name: bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology 22ga 1. 00in device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that an unspecified number of bd insyte¿ autoguard¿ bc winged shielded iv catheters blood control technology 22ga 1. 00in experienced loose needles which were noted during use. The following information was provided by the initial reporter: material no. : 382623, batch no. : unknown. Verbatim: the main concern i keep hearing is that the needle is not sharp enough. Another concern out nurses have is that the catheter does not stay secure around the needle while inserting it. This morning a nurse was opening a needle and as she was opening it the needle bent.
 
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Brand NameSEE H.10
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9838655
MDR Text Key186752571
Report Number1710034-2020-00179
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903826231
UDI-Public30382903826231
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382623
Device Catalogue Number382623
Device Lot NumberUNKNOWN
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 Received02/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/17/2020 Patient Sequence Number: 1
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