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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 5.5FR X 13CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 5.5FR X 13CM; CATHETER PERCUTANEOUS Back to Search Results
Model Number IPN031685
Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported: on (b)(6) 2020 in the morning, the bandage was soaked of a liquid (that was not blood).The leaked happened at the juncture where the catheter is attached to the patient.It was a leak of the product being infused.It looked like the catheter was pierced but the hole was invisible.Clinical consequences: there was no consequence for the patient, except that the involved catheter was removed, and new venous line was inserted, a delay of treatment and discomfort for the patient.
 
Manufacturer Narrative
(b)(4).The customer returned one three-lumen catheter for evaluation.The juncture hub was observed to have been sutured.Visual examination of the returned catheter did not reveal any defects or anomalies.The overall length of the catheter body measured 5.50" which is within specification of 5.25-5.75" per product drawing.The catheter was initially flushed to ensure there were no blockages.The distal end of the catheter was then clamped and a lab inventory syringe was used to pressurize each lumen.No leaks were detected.The catheter was then tested for liquid leakage per bs en iso 10555-1 annex c.This states that there shall be no liquid leakage in the form of a falling drop when pressurized to 300kpa for 30 seconds.The catheter was connected to the leak tester and pressurized to 300 kpa for 30 seconds.No leaks were observed from any region of the catheter.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user "do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of a juncture hub leak could not be confirmed by functional testing of the returned catheter.The catheter passed all relevant visual and functional tests, and a device history record review was performed with no relevant findings.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaint of this nature.
 
Event Description
It was reported: on (b)(6) 2020 in the morning, the bandage was soaked of a liquid (that was not blood).The leaked happened at the juncture where the catheter is attached to the patient.It was a leak of the product being infused.It looked like the catheter was pierced but the hole was invisible.Clinical consequences: there was no consequence for the patient, except that the involved catheter was removed, and new venous line was inserted, a delay of treatment and discomfort for the patient.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 5.5FR X 13CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10123032
MDR Text Key194626832
Report Number3006425876-2020-00497
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 company representative,foreig
Type of Report Initial,Followup
Report Date 05/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN031685
Device Catalogue NumberEU-16553-N
Device Lot Number71F19M0823
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Date Manufacturer Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age2 YR
Patient Weight14
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