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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); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Date 08/24/2019
Event Type  malfunction  
Manufacturer Narrative
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. Unknown manufacturer: 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. (b)(4).
 
Event Description
It was reported that the 22g x 1. 00in (0. 9 x 25 mm) insyte experienced product damage/deformation which was noted during use. The following information was provided by the initial reporter: material no. : 381223 batch no. : unknown it was reported that the tip of the catheter broke off while it was inside the patient so it had to be removed surgically. Per phone call on 8/27/29: health professional from user facility indicated that the catheter tip broke off inside the patient. Patient was a dog. Happened early morning (b)(6) 2019. Broken piece had to be removed surgically but was retrieved and patient is stable. Possible lots 8265303 & 8265298.
 
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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 MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8982448
MDR Text Key158788291
Report Number2243072-2019-01962
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Yes
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: 09/10/2019 Patient Sequence Number: 1
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