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

Model Number	IPN030078
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
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
Qn#(b)(4).Associated mdr#s: 3006425876-2022-01108; and 3006425876-2022-01098.
Additional Manufacturer Narrative
(b)(4).Associated mdr#s: 3006425876-2022-01108; 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.The separated portion was not returned.Initial visual inspection of the catheter and extension lines did not reveal any obvious defects or anomalies.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 medial extension line outer diameter measured 2.201mm, which is within the specifications of 2.13mm-2.21mm per product drawing.The medial 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) provided with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the medial extension line were flushed using a lab inventory 10ml syringe.The lumen was able to flush as expected and no blockages or occlusions were noted.Functional testing of the separated portion of the catheter body could not be performed as it was not returned for evaluation.It cannot be determined if a blockage or occlusion was present in the separated portion of the catheter.The medial extension line was tested for liquid leakage per amrq-000071 rev.12 (bs en iso 10555-1 annex c) which states that no liquid leakage should form in one or more falling drops of water when tested at 300kpa for 30 seconds.The medial extension line was separately attached to the leak tester , the distal tip of the catheter was occluded, and the leak tester was turned to 300 kpa for 30 seconds.No leaks were found anywhere on the catheter body or extension line.The customer report of a blockage on the medial extension lumen could not be confirmed, however a blockage was observed on the proximal lumen.The source of the blockage was determined to be dried biological material within the line which is consistent with unintentional use error.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 ifu also instructs the user "maintain catheter patency according to institutional policies, procedures and practice guidelines.All personnel who care for patients with central venous catheters must be knowledgeable about effective management to prolong catheter's dwell time and prevent injury.".The customer report of a blocked extension line could not be confirmed through complaint investigation of the returned sample.The catheter met all relevant dimensional requirements.No blockages were observed during flush testing of the medial lumen; however, testing of the separated portion of the catheter body could not be performed as it was not returned for evaluation.Functional leak testing was also performed on the medial lumen according to bs en iso 10555-1 annex c and no leaks were observed.Based on the customer report, and without the separated portion of the catheter returned for analysis, the probable root cause could not be determined.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 catheter 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: 15991831
• Report Number: 3006425876-2022-01107
• Device Sequence Number: 20242942
• 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