MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 11CM; CATHETER, PERCUTANEOUS

Catalog Number CV-10854

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2023

Event Type  malfunction  

Event Description

It was reported that: "cvc fell out of the patient.When examined the sutures had sliced through the plastic on the cvc".The patient's condition was unknown.Additional information was requested but was not available at the time of this report.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer reported that they observed the "sutures had sliced through the plastic on the cvc." 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." a device history record review was performed, and there was one potential finding of catheter box clamp deformed, for which a customer complaint was initiated.However, it cannot be confirmed without the returned sample that if the failure mode of this complaint is the same as the finding identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: "cvc fell out of the patient.When examined the sutures had sliced through the plastic on the cvc." the patient's condition was unknown.Additional information was requested but was not available at the time of this report.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cvc catheter for analysis.Visual examination of the catheter revealed that one of the suture wings on the juncture hub was torn.The observed tear in the suture wings did not occur at the molding seam.The appearance of the tear was consistent with undue force being applied during use.The damage to the suture wings likely caused or contributed to the catheter migration.The customer also noted the damage to the suture wings upon seeing the catheter migration.A discrepancy was noted between the reported finished good material (4-lumen 8.5fr x 11cm) and the returned sample (4-lumen 8.5fr x 16cm).No further clarification could be provided by the customer.Since the observed damage matched the customer description, the sample was investigated as part of this complaint, and it was assumed that the incorrect material number was reported.The customer did not provide a lot number; therefore, a device history record review was performed based upon three potential lot numbers identified from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "precaution: minimize catheter manipulation throughout procedure to maintain proper catheter tip position.".The customer report of catheter migration was confirmed through investigation of the returned sample.One of the suture wings of the catheter was observed to be torn, which likely caused or contributed to the catheter migration.The appearance of the suture wings damage was consistent with undue force being applied.Therefore, based on the customer description and the received sample, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported that: "cvc fell out of the patient.When examined the sutures had sliced through the plastic on the cvc." the patient's condition was unknown.Additional information was requested but was not available at the time of this report.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 11CM
• Type of Device: 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: 17259204
• MDR Text Key: 318596581
• Report Number: 3006425876-2023-00638
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

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 Catalogue Number: CV-10854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 07/25/2023; 09/27/2023
• Supplement Dates FDA Received: 07/27/2023; 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NOT REPORTED; NOT REPORTED; NOT REPORTED