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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
Lot Number 13F21H1316
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Separation Problem (4043)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/10/2021
Event Type  malfunction  
Event Description
Picc line was being placed in pt left cephalic vein. Vein access was uneventful, but when threading the picc through the sheath, the handles on the sheath came off of the sheath that was in the vein. Therefore the 7 cm sheath was inside the patient's vein and there was no way to remove the sheath. Attempted removal by interventional radiology (ir) nurse practitioner and also ir doctor but unable to do so. Vascular surgeon was called and will take patient to or to remove.
 
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Brand NameARROW
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key13017775
MDR Text Key282329876
Report Number13017775
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 11/11/2021,11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number13F21H1316
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2021
Event Location Hospital
Date Report to Manufacturer12/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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