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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 55 CM; INTRODUCER, CATHETER
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ARROW INTERNATIONAL INC. ARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 55 CM; INTRODUCER, CATHETER Back to Search Results
Catalog Number CDC-45552-VPS2
Device Problems Knotted (1340); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports when attempting to remove the needle over the wire, the needle would not glide over the wire.The wire looked as if there was a tiny knot that was impeding its removal.The needle and guidewire were removed as one unit.A new insertion kit was used.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not supply a lot number; therefore, a potential lot number was determined from a sales history review for this customer.A device history record review was performed on the guide wire and introducer needles from the potential lot and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports when attempting to remove the needle over the wire, the needle would not glide over the wire.The wire looked as if there was a tiny knot that was impeding its removal.The needle and guidewire were removed as one unit.A new insertion kit was used.
 
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Brand Name
ARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 55 CM
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7483026
MDR Text Key107317269
Report Number1036844-2018-00127
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCDC-45552-VPS2
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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