MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VESSEL CATH SET: 24 GA X 9CM; CATHETER, PERCUTANEOUS

Model Number	IPN031491
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "patient is a new born baby.A central catheter was inserted in surgery room in jugular on (b)(6) 2021.The baby was sent back to his room.The bandage was not fully covering, the pressure valve was visible.We performed a x ray in the room, the child was a bit agitated.Whilst removing the x ray plaque, the bandage was slighlty opened and the catheter was out.This event was reported to the doctor.The doctor asked to remove the bandage from the catheter.When we removed the bandage, the juncture hub was properly attached but the catheter was separated from the hub.The catheter slid and went out of the skin.A dry bandage was applied.Doctors decided to send the child to surgery room to insert a new catheter.".
Event or Problem Description
The complaint is reported as: "patient is a new born baby.A central catheter was inserted in surgery room in jugular on (b)(6) 2021.The baby was sent back to his room.The bandage was not fully covering, the pressure valve was visible.We performed a x ray in the room, the child was a bit agitated.Whilst removing the x ray plaque, the bandage was slightly opened and the catheter was out.This event was reported to the doctor.The doctor asked to remove the bandage from the catheter.When we removed the bandage, the juncture hub was properly attached but the catheter was separated from the hub.The catheter slid and went out of the skin.A dry bandage was applied.Doctors decided to send the child to surgery room to insert a new catheter.".
Additional Manufacturer Narrative
(b)(4).Additional information received from the customer: "there was no consequence for the baby because all the medical staff were pro-active and inserted a second catheter quickly and the treatment was performed with success." the customer returned a single-lumen catheter and a catheter clamp for evaluation.The catheter clamp fastener was not returned.Visual inspection of the catheter did not reveal and defects or anomalies.The length of the catheter body measured 3.375", which is within specifications of 3.0625"-3.5625" per catheter product drawing.The outer diameter of the catheter body measured 0.02960", which is within specifications of 0.029-0.033" catheter extrusion graphic.The inner diameter of the catheter body at the distal end measured 0.023", which is within specifications of 0.020-0.024" catheter extrusion graphic.The catheter was flushed per ifu which states, "prepare catheter for insertion by flushing the lumen." when the catheter was flushed no leaks were detected.A lab inventory guide wire with an outer diameter of.018" was inserted through the catheter per ifu.Little to no resistance was observed.The returned clamp catheter and a lab inventory clamp fastener were assembled on the catheter body per ifu to form a box clamp assembly.The catheter was pulled on while holding the box clamp assembly still, but the catheter did not move.A manual tug test confirmed that the luer hub was secure and intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit warns the user, "do not cut catheter to alter length.Do not suture directly to outside diameter of catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow." the report of a catheter migrating could not be confirmed through complaint investigation.The returned catheter passed all functional and dimensional testing.A device history record review was performed, and no relevant findings were identified.Without the clamp fastener the complaint could not be confirmed and a root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW VESSEL CATH SET: 24 GA X 9CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11447843
• Report Number: 3006425876-2021-00206
• Device Sequence Number: 17048630
• Product Code: DQY
• UDI-Device Identifier: 00801902009913
• UDI-Public: 00801902009913
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: IPN031491
• Device Catalogue Number: ES-04650
• Device Lot Number: 71F20J2392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1