• 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. HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CHRONIC HEMODIALYSIS PRODUCTS

  • 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. HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CHRONIC HEMODIALYSIS PRODUCTS Back to Search Results
Catalog Number CS-15282-VSP
Device Problems Material Fragmentation (1261); Material Separation (1562)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 04/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this (b)(6)/old female chronic dialysis patient had a cannon ii plus catheter in place for 5 years.In (b)(6) lab, the catheter removal procedure was performed due to bacteremia.The clinician reports that during the retrieval process, it became apparent that the cuff of the permcath had separated from the catheter itself and appeared to be in the multiple pieces, well incorporated into the patient's scar tissue.The cuff was unable to be retrieved resulting in portions of catheter cuff remain in patient subcutaneous layer.There was no reported death or complications to the patient as a result of this occurrence.The patient is doing well.
 
Manufacturer Narrative
Qn#(b)(4).Device evaluation: it was reported that the cannon ii plus catheter had been in situ for 5 years.In medical imaging - interventional radiology lab, the catheter removal procedure was performed due to bacteremia.The clinician reports that during the retrieval process, it became apparent that the cuff of the permcath had separated from the catheter itself and appeared to be in the multiple pieces, well incorporated into the patient's scar tissue.The cuff was unable to be retrieved resulting in portions of catheter cuff remain in patient subcutaneous layer.One chronic hemodialysis catheter was returned.The catheter cuff was not returned.The instruction booklet cautions that chronic dialysis catheters should not be used for extended use unless no other hemodialysis access options exist; they should be used only as bridge devices.The instructions for use states to use the exit site mark on catheter to ensure the cuff is positioned properly.The site maintenance procedures specify that the exit site and dressing must be kept clean and dry.A device history record review could not be performed since the lot number was not reported by the customer and could not be determined because of the length of use.Verification testing could not be performed because the other remarks: cuff was not returned for evaluation.However, based on the report that the catheter had been in situ for five years, operational context caused or contributed to this event.No further action will be taken.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
Type of Device
CHRONIC HEMODIALYSIS PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX   31114
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5630837
MDR Text Key44386546
Report Number3003737899-2016-00024
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K111117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 04/21/2016
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 Health Professional
Device Catalogue NumberCS-15282-VSP
Device Lot NumberUNKNOWN
Other Device ID Number00801902096388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/21/2016
Initial Date FDA Received05/04/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/27/2016
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
Patient Age81 YR
-
-