MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER SUBCLAVIAN

Model Number IPN919725

Device Problem Break (1069)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

It was reported "during the channeling of the syringe, the plastic cone came off." and "the ifus were followed (cleansing of the skin with chlorhexidine and drying)".The anatomical insertion site was the jugular.The issue was resolved by using another catheter.There was no patient harm or injury.The patient's current condition is reported as "good".

Manufacturer Narrative

(b)(4).

Event Description

It was reported "during the channeling of the syringe, the plastic cone came off." and "the ifus were followed (cleansing of the skin with chlorhexidine and drying)".The anatomical insertion site was the jugular.The issue was resolved by using another catheter.There was no patient harm or injury.The patient's current condition is reported as "good".

Manufacturer Narrative

(b)(4).The customer provided five photos for evaluation.Four of the photos show a portion of the needle hub broken.The images show that the rest of the needle hub is still attached to the needle cannula.One image shows the product lidstock.The customer returned one introducer needle for analysis.Signs of use were observed on the needle cannula.Visual analysis revealed that a portion of the needle hub broke off from the hub.The separated portion was not returned.Additional cracks were noted on the portions of the hub that were still attached.The needle cannula was still attached to the rest of the needle hub.It was also confirmed that the hub on the returned sample is the new hub design, which matches the bill of materials.Functional inspection was not able to be performed due to the damage to the needle hub.A device history record review was performed, and no relevant findings were identified.The report of a broken needle hub was confirmed by complaint investigation of the returned sample.Visual examination revealed the hub was broken.A device history record review was performed, and no relevant findings were identified.Based on the sample provided, design caused or contributed to this event.Further investigation of this issue is being performed under a capa.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER SUBCLAVIAN
• 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: 15484438
• MDR Text Key: 305691239
• Report Number: 3006425876-2022-00831
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K895417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN919725
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 71F22B1248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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