MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CENTRAL VENOUS CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number VASCULAR UNKNOWN

Device Problem Obstruction of Flow (2423)

Patient Problem Extravasation (1842)

Event Date 08/08/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that " pediatric cvc placed (b)(6) 2023.Incident happened during injection of contrast media with syringe pump.There have been problems with precipitates in hoses from a lime infusion a few days earlier.They then took actilyse and put it in the line as treatment, but it was difficult to get actilyse into the line, so doctors had to forcefully press it in and quickly close the line.After treatment with actilyse, the line functioned.Before ct, contrast was injected with a "syringe pump", only when the images came up on the ct display it was discovered that all the contrast was up in the thorax and not in the blood system.The examination was interrupted, and the patient had to be transported back to the icu, where they had to go into surgery and insert a new cvc.Additional information has been requested from the account.

Manufacturer Narrative

(b)(4).The customer returned one pediatric cvc (3 lumen 5.5fr x 8 cm) for analysis.Signs of use in the form of biological material was observed inside the catheter body.Visual and microscopic examination of the proximal and medial skive holes revealed a build-up of dried biological material.The distal hole also had biological material at the tip.Functional testing was performed per cvc ifu guidelines: "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A lab inventory syringe filled with water was attached to all three extension lines and flushed.No defects were observed when flushing the distal and proximal lumens.However, when the medial line was flushed, the fluid exited out of the proximal catheter body.The complaint of catheter leaked in use was confirmed.Further inspection revealed that the catheter body had a large protrusion that was exposed.Proximal to the protrusion was the hole where the fluid leaked.Continuing beyond the protrusion was evidence of additional catheter deformation.No fluid was able to flow out of the medial skive hole.This is consistent with the customer report of "it was discovered that a ll the contrast was up in the thorax and not in the blood system".R & d engineering was consulted as part of this investigation.The consultation confirmed, based on the customer report and sample received, that use error related to over pressurizing the catheter during use caused or contributed to this event.The instructions for use (ifu) provided with cvc kits warn the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture." the report of catheter leaked in use was confirmed based on the sample received.Visual inspection revealed normal signs of use with significant biological material in both skive holes.Functional inspection revealed that when the medial line was flushed, the fluid exited out of a hole in the proximal catheter body.Further inspection revealed that the catheter body had a large protrusion that was exposed.Proximal to the protrusion was the hole where the fluid leaked.Continuing beyond the protrusion was evidence of additional catheter deformation.No fluid was able to flow out of the medial skive hole.This is consistent with the customer report of "it was discovered that all the contrast was up in the thorax and not in the blood system".Additionally, the customer reported the following: "they took actilyse and put it in the line as treatment, but it was difficult to get actilyse into the line, so doctors had to forcefully press it in and quickly close the line".The instructions for use (ifu) provided with cvc kits warn the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture".Based on the customer report, sample received, and consultation with r & d engineering, it was concluded that use error related to over pressurizing the catheter during use caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that " pediatric cvc placed (b)(6) 2023.Incident happened during injection of contrast media with syringe pump.There have been problems with precipitates in hoses from a lime infusion a few days earlier.They then took actilyse and put it in the line as treatment, but it was difficult to get actilyse into the line, so doctors had to forcefully press it in and quickly close the line.After treatment with actilyse, the line functioned.Before ct, contrast was injected with a "syringe pump", only when the images came up on the ct display it was discovered that all the contrast was up in the thorax and not in the blood system.The examination was interrupted, and the patient had to be transported back to the icu, where they had to go into surgery and insert a new cvc.Additional information has been requested from the account.

• Brand Name: CENTRAL VENOUS CATHETER
• 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: 17727669
• MDR Text Key: 323147787
• Report Number: 3006425876-2023-00928
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention