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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW INTRODUCER, CATHETER

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TELEFLEX INCORPORATED ARROW INTRODUCER, CATHETER Back to Search Results
Model Number IPN036456
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 06/16/2020
Event Type  malfunction  
Event Description
From staff: patient turned side to side. Change in pulmonary artery catheter waveform noted, at same cm marking of 54cm. Noticed right internal jugular (ij) vein central venous catheter inadvertently pulled out partially. Dr on unit and advanced line at bedside, stat chest x-ray done to confirm placement of ij & swanganz line. No change in vital signs during this, all meds infusing through swan.
 
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Brand NameARROW
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key10546263
MDR Text Key207367945
Report Number10546263
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN036456
Device Catalogue NumberCDC-09803-1A
Device Lot Number13F19K0445
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/03/2020
Event Location Hospital
Date Report to Manufacturer09/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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