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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 16G X 1.16IN (1.7 X 30 MM) ANGIOCATH INTERVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 16G X 1.16IN (1.7 X 30 MM) ANGIOCATH INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381154
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/05/2019
Event Type  Injury  
Manufacturer Narrative
The lot# is unknown but the customer provided 3 possible lot#s. The information for each lot number is as follows: medical device lot #: 6063764; expiration date: 2021-03-31; manufacture date: 2016-04-04. Medical device lot #: 4325585; expiration date: 2019-12-31; manufacture date: 2015-01-05. The reported lot# 7051292 was not found for the catalog number. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a catheter broke during use with a 16g x 1. 16in (1. 7 x 30 mm) angiocath. The following information was provided by the initial reporter, "during the removal of the catheter they realized that a part of it remained in the vein. An urgent ultrasound scan was performed and the broken catheter was removed by a surgical intervention. The list of medicines that was used with the catheter: cefamezin iv 1fl 1g+f 10 ml; tranex os iv 6f 5 ml 500 mg; cefazolina teva iv f 1g+f 10 ml; elettrolitica reintegro na 20 sacc 500 ml; sodio cloruro 0. 9 %; flexen iv 6f 100 mg+6 f 5 ml; plasil iniettabile 5f 10mg/2ml; morfina cl 5f 1ml 10mg/ml; perfalgan ev 10mg/ml 100 ml. ".
 
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Brand Name16G X 1.16IN (1.7 X 30 MM) ANGIOCATH
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9256508
MDR Text Key180441454
Report Number9610847-2019-00653
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSM
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 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381154
Device Lot NumberSEE H.10
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 Received10/09/2019
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: 10/30/2019 Patient Sequence Number: 1
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