• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ANGIOCATH SPECIAL ORN 14GA X 5.25IN INTRAVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ANGIOCATH SPECIAL ORN 14GA X 5.25IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382269
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/03/2021
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd angiocath special orn 14ga x 5. 25in catheter had broken off inside the horse. The following information was provided by the initial reporter: a bd angiocath venous catheter had been in the jugular vein of a horse since thursday afternoon (b)(6) 2021). The vein access was laid by an experienced veterinarian without complications. In the night from saturday, (b)(6) to sunday, (b)(6) the horse got a lot with a swollen catheter puncture site. The fastening skin suture was loosened to remove the venous catheter from the vein. Much to the fact that this was only about 1. 5cm long. The rest of the catheter had obviously broken off. During the ultrasound examination, the rest of the catheter could no longer be found, there is a suspicion that it was carried into the right ventricle of the heart. Is the product is available for examination: yes, it can be picked up at the address of the reporting person (horse clinic at (b)(6). Were there any injuries to the user, patient or third party ?: yes, the horse is now unusable for riding due to the risk of thrombosis/pulmonary embolism, resulting in an almost complete loss of value. Additional important information: death: no, but possible in the future. Serious injury: yes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD ANGIOCATH SPECIAL ORN 14GA X 5.25IN
Type of DeviceINTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12737197
MDR Text Key279562441
Report Number9610847-2021-00526
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number382269
Device Lot Number0329670
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2020
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: 11/02/2021 Patient Sequence Number: 1
-
-