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

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER, PERCUTANEOUS

  • 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
 

ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number ES-04301
Device Problems Device Damaged Prior to Use (2284); Folded (2630)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports the guide is shown folded in the distal part.The issue was detected prior to use.The procedure is performed with the device and without complications.
 
Event Description
The customer reports the guide is shown folded in the distal part.The issue was detected prior to use.The procedure is performed with the device and without complications.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW CVC SET: 16 GA X 8" (20 CM)
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7421470
MDR Text Key105423279
Report Number9680794-2018-00072
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/31/2022
Device Catalogue NumberES-04301
Device Lot Number14F17J0117
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/27/2018
Initial Date FDA Received04/11/2018
Supplement Dates Manufacturer Received05/15/2018
Supplement Dates FDA Received05/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
Patient Weight63
-
-