Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 LLC DRAINAGE SET; CATHETER IRRIGATION
  • 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 LLC DRAINAGE SET; CATHETER IRRIGATION Back to Search Results
Catalog Number AI-01600
Device Problems Device Dislodged or Dislocated (2923); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2024
Event Type  malfunction  
Event Description
It was reported that: patient had drain for pleural effusion and the catheter slipped out through the tied down wings.Catheter was found in bed and wings still sutured to skin.There was no reported patient harm or consequence.The patient was reported as fine.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon two lot numbers taken from the sales history data of the customer.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
It was reported that: patient had drain for pleural effusion and the catheter slipped out through the tied down wings.Catheter was found in bed and wings still sutured to skin.There was no reported patient harm or consequence.The patient was reported as fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DRAINAGE SET
Type of Device
CATHETER IRRIGATION
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18824752
MDR Text Key336754791
Report Number9680794-2024-00160
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00801902097903
UDI-Public00801902097903
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K895516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAI-01600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2024
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
Treatment
NOT REPORTED; NOT REPORTED
Patient Age76 YR
Patient SexMale
-
-