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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS Back to Search Results
Catalog Number ES-04301
Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2023
Event Type  malfunction  
Event Description
It was reported "the drainage tube was placed by the ultrasound department on (b)(6) 2023 at 19:20.On (b)(6) 2023, the patient's family members went to the nursing station to complain that the patient's abdominal catheter was missing.The supervising nurse looked at the patient's bedside and found that there was no abdominal catheter, and there was leakage from the abdominal puncture opening.The dressing was completely soaked and moist, and the right ascites continued to seep out.The puncture opening was compressed with gauze.When searching, it was found that the abdominal catheter was in the pants leg, the tube end was intact, and the patient complained of no discomfort.The doctor on duty was informed, the on duty doctor changed the dressing at the bedside and, if necessary, made a pocket without resetting the drainage tube." the patient's condition 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.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.
 
Event Description
It was reported "the drainage tube was placed by the ultrasound department on (b)(6) 2023 at 19:20.On (b)(6) 2023, the patient's family members went to the nursing station to complain that the patient's abdominal catheter was missing.The supervising nurse looked at the patient's bedside and found that there was no abdominal catheter, and there was leakage from the abdominal puncture opening.The dressing was completely soaked and moist, and the right ascites continued to seep out.The puncture opening was compressed with gauze.When searching, it was found that the abdominal catheter was in the pants leg, the tube end was intact, and the patient complained of no discomfort.The doctor on duty was informed, the on duty doctor changed the dressing at the bedside and, if necessary, made a pocket without resetting the drainage tube." the patient's condition was reported as fine.
 
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Brand Name
ARROW CVC SET: 16 GA X 8" (20 CM)
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17108195
MDR Text Key317465352
Report Number3006425876-2023-00561
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberES-04301
Device Lot Number71F22B0232
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2022
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
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