• 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 KIT: 2-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

  • 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 KIT: 2-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CA-22702
Device Problems Crack (1135); Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 01/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports a cracked tray.
 
Manufacturer Narrative
Qn#(b)(4).The customer did not return the sample; however one photo was provided of the defective sample.Visual inspection of the photo confirmed that the outer tray had cracked.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The complaint of a cracked tray was confirmed by the photo the customer sent.A device history record review was performed and no relevant findings were identified.The probable cause of this defect is design related.A non-conformance has been created to further investigate this cracked tray, sterility issue.
 
Event Description
The customer reports a cracked tray.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW CVC KIT: 2-LUMEN 7 FR X 16 CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9693993
MDR Text Key178588483
Report Number9680794-2020-00080
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/31/2020
Device Catalogue NumberCA-22702
Device Lot Number13F19B0482
Was Device Available for Evaluation? No
Date Manufacturer Received03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NA.; NA.
-
-