MAUDE Adverse Event Report: COOK INCORPORATED COOK SPECTRUM TURBO-JECT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number G05676

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2021

Event Type  malfunction  

Event Description

The mother of the patient pressed the call light and said that the patient's line was "leaking." upon entering the room, the nurse found fluid dripping off of the cook spectrum turbo-ject power-injectable picc.The patient was just running maintenance iv fluid at that point.The tubing and all connections were secured, yet fluid was leaking as the pump was infusing.There was maybe approximately 5 ml of fluid or so on the floor.Nurse delayed the pump, detached the tubing from the patient and put a cap on the iv tubing that had been infusing to try to identify where the fluid was coming from.As soon as nurse detached the fluid that had been infusing, there was a small amount of blood that started leaking out of the line.Nurse grabbed the atraumatic clamp that was in the drawer and clamped it right in the middle of the clave and where the picc line was sutured in.The blood continued to leak slowly, so nurse moved the atraumatic clamp up just below the bottom of the dressing, at which point the blood stopped flowing and the line was no longer leaking.There appeared to be a small hole in the line approximately 5 cm above the clave.Nurse immediately called the charge nurse on vocera and she came and looked at the line then went to the doctor room to discuss options going forward.Nurse stayed at the bedside to ensure that the atraumatic clamp would stay in place and the doctor's team made the decision in the following 5 minutes to have the line pulled.Nurse pulled the picc line shortly after that.There was very minimal fluid where the patient had been sitting, reflecting that the line break probably happened pretty soon after the mom pressed the call light.The mom was with the patient the entire time as well.Nurse had also been in the room 15 minutes earlier and saw the dressing and the patient's line which had no issues at the time.Additionally, the blood that leaked was probably approximately 3 ml total by the time nurse got the atraumatic clamp placed in the right spot on the line.Nurse have no insight into how it ended up with what appeared to be a hole in it.

• Brand Name: COOK SPECTRUM TURBO-JECT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 13415208
• MDR Text Key: 284808441
• Report Number: 13415208
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: G05676
• Device Catalogue Number: UPICS-3.0-CT-NT-ABRM-1110
• Device Lot Number: 13724268
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1460 DA
• Patient Sex: Female