MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3L 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN030078
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Associated mdr#s: 3006425876-2022-01107; and 3006425876-2022-01098.
Event or Problem Description
It was reported the nurse went to sample blood from the catheter that had been inserted on 28 october and found the proximal line was leaking.The medial line had no reflux (blockage/occlusion), and the distal line was wrapped in a band and had an anti-reflux connector on it.The band was removed and the line was checked.There was no reflux but presence of air and leaks and the line had a hole in it.The distal line was immediately clamped and the cather was removed.A chest x-ray was performed.It was reported there was no patient injury and no medical intervention was required.The patient's condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Associated mdr#s: 3006425876-2022-01107; 3006425876-2022-01098.The customer returned one 3-l cvc for analysis.Signs of use were observed on the catheter body and inside the extension lines.The catheter appeared intentionally cut.Initial visual inspection of the catheter and extension lines did not reveal any obvious defects or anomalies.After performing functional testing (see below), further visual inspection of the distal extension line revealed a small v-shaped hole in its body.This appearance of the hole is consistent with unintentional contact with sharps (i.E.Scalpel, scissors, etc.) during use.The catheter body length measured 88mm, which is not within the specifications of 157mm-177mm per product drawing.This indicates that 69mm-89mm of the catheter were cut and not returned for analysis.The distal extension line outer diameter measured 2.166mm, which is within the specifications of 2.13mm-2.21mm per product drawing.The proximal extension line inner diameter measured 1.4732mm, which is within the specifications of 1.42mm-1.50mm per product drawing.This indicates that the wall thickness measured within specifications.Functional inspection of the catheter was performed per the instructions-for-use (ifu) provide d with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the extension lines were flushed using a lab inventory 10ml syringe.A leak was observed partway down the distal extension line body.A manual tug test confirmed the extension lines were fully secured within their respective hubs.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (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 an extension line leak was confirmed through complaint investigation of the returned sample.A leak was observed partway down the distal extension line.Visual inspection of the extension line revealed a small hole consistent with unintentional contact with sharps (i.E.Scalpel, scissors, etc.) during use.Based on the appearance of the damage and the customer report that the leak was identified during use, unintentional use error (contact with sharps) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported the nurse went to sample blood from the catheter that had been inserted on 28 october and found the proximal line was leaking.The medial line had no reflux (blockage/occlusion), and the distal line was wrapped in a band and had an anti-reflux connector on it.The band was removed and the line was checked.There was no reflux but presence of air and leaks and the line had a hole in it.The distal line was immediately clamped and the cather was removed.A chest x-ray was performed.It was reported there was no patient injury and no medical intervention was required.The patient's condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3L 7 FR X 16 CM
• Common Device Name: 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 Key: 15991817
• Report Number: 3006425876-2022-01108
• Device Sequence Number: 12252547
• Product Code: DQY
• UDI-Device Identifier: 00801902102133
• UDI-Public: 00801902102133
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2022

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 Model Number: IPN030078
• Device Catalogue Number: CS-12703-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown