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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON 22G X 1.00IN (0.9 X 25 MM) INSYTE INTERVASCULAR CATHETER

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BECTON DICKINSON 22G X 1.00IN (0.9 X 25 MM) INSYTE INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381223
Device Problems Leak/Splash (1354); Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2019
Event Type  malfunction  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It has been reported that the 22 g x 1. 00 in (0. 9 x 25 mm) insyte has been found with the catheter disconnected during use. The following has been provided by the initial reporter: the metal guide is disassociated from the catheter when the blister is opened.
 
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Brand Name22G X 1.00IN (0.9 X 25 MM) INSYTE
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8853121
MDR Text Key153154939
Report Number2243072-2019-01566
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K151698
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,Followup
Report Date 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381223
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 Received07/17/2019
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: 08/01/2019 Patient Sequence Number: 1
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