MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the luer-hub (brown) was leaking".No patient harm reported.The device was replaced.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 3-l cvc for investigation.The distal luer hub was not returned.The catheter body was intentionally severed.Visual inspection revealed the distal luer hub separated from its extension line.The point of separation is unknown as the distal luer hub was not returned.The separation point on the extension line was rough and jagged.Visual inspection of the separated hub could not be performed as it was not returned for evaluation.It was noted during dimensional inspection that the returned catheter is a 7 fr.30 cm catheter, while the reported material number for this complaint includes a 7 fr.20 cm catheter.Additional information was requested, and it was determined that the customer does not have any information that could clear the mismatch.It is unknown whether the customer returned the wrong sample for this complaint or whether they reported the wrong material number.The catheter body length measured 259mm, which is not within the specification of 207mm-227mm per catheter product drawing.Upon further inspection of the labeling on the catheter juncture hub, it was noted that the returned catheter is a 30 cm catheter, while the reported catheter is a 20 cm catheter.Therefore, the product drawings for the reported material number do not correspond to the returned sample.The returned distal extension line outer diameter measured 2.183mm.This is within the specification of 2.13mm-2.21mm per product drawing.The distal extension line inner diameter measured 1.4732mm.This is within the specification of 1.42mm-1.50mm per product drawing.However, the referenced distal extension line product drawing does not necessarily correspond to the returned sample.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the medial and proximal extension lines were flushed using a 5cc syringe.Both extension lines flushed as expected.A manual tug test confirmed the medial and proximal extension lines were secure to their respective hubs.A device history record review was performed and 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/luer hub separation was confirmed by complaint investigation of the returned sample.The distal extension line separated from its luer hub; however, the separated luer hub was not returned for evaluation.The probable root cause of this event could not be determined without the luer hub returned for analysis.Additionally, the reported material number for this complaint does not match the returned sample.Based on these circumstances, the probable root cause for this complaint due to the discrepancy between the reported catheter and the returned catheter.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported "the luer-hub (brown) was leaking".No patient harm reported.The device was replaced.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 14378629
• MDR Text Key: 291615039
• Report Number: 3006425876-2022-00455
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• 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: 04/20/2022

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
• Device Expiration Date: 06/23/2023
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F21F2502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1