MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 30CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number IPN916312

Device Problem Material Separation (1562)

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

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: sors.(b)(4).

Event Description

It was reported the puncture needle separated from the plastic hub during cvc placement under ultrasound.It was reported the patient's condition was unchanged and stable.

Manufacturer Narrative

Continuation of d11: sors (b)(4).The customer returned an introducer needle for analysis.Signs of use in the form of biological material were observed inside the needle hub.Visual analysis revealed that the needle hub was broken and separated.A portion of the distal end of the hub was still adhered to the needle cannula.Microscopic examination revealed that the point of separation was slightly rough and not uniform.When reassembled, a notch was observed in the needle hub which is consistent with the new hub design.The hub of the needle was tested with the male luer gage and was within the specified range.This indicates that the luer conforms to iso 594-1:1986.A device history record review was performed, and no relevant findings were identified.The report of a separated needle hub was confirmed by complaint investigation of the returned sample.Visual examination revealed the hub was separated.The hub of the needle was tested with the male luer gage and was within the specified range, indicating that the luer conforms to iso 594-1:1986.A device history record review was performed, and no relevant findings were identified.Based on the sample provided and the customer report that disinfectant was used, 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.

Event Description

It was reported the puncture needle separated from the plastic hub during cvc placement under ultrasound.It was reported the patient's condition was unchanged and stable.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 30CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 14458342
• MDR Text Key: 292204557
• Report Number: 3006425876-2022-00474
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/08/2023
• Device Model Number: IPN916312
• Device Catalogue Number: AD-24854
• Device Lot Number: 71F21G0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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
• Treatment: OCTIDERM DISINFECTANT SPRAY, STERILE GEL, VASOPRES.; OCTIDERM DISINFECTANT SPRAY, STERILE GEL, VASOPRES.
• Patient Age: 63 YR