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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW CATHETER, INTRAVASCULAR, THERAPEUTIC

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TELEFLEX INCORPORATED ARROW CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN037300
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2018
Event Type  malfunction  
Event Description
Rn prepared to place picc line and discovered upon opening the packaging that the picc was packaged wrong. A 40cm picc line had been packaged in error as a 50cm picc line. The 40cm picc line was not placed in patient. Rn obtained a new 50cm picc line package and placed the line without complication.
 
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Brand NameARROW
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key8068513
MDR Text Key127117587
Report Number8068513
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN037300
Device Catalogue NumberCDC-45052-VPS2
Device Lot Number23F 18F0005
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2018
Event Location Hospital
Date Report to Manufacturer11/14/2018
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

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