MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW; WIRE, GUIDE, CATHETER

Model Number IPN037314

Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

Patient found to be bleeding from right radial arterial line, saturating pillow hand was on.Dressing taken down to be changed when significant amount of blood squirting out from the area of the catheter closest to the line attached.Occluded with gauze and arterial line removed.This has happened on 6 occasions in the last 2 months.4 of the catheters were sent to teleflex arrow international for investigation.Manufacturer response for arrow arterial access kit ask-04001-bid2, arterial access kit ask-04001-bid2 (per site reporter): email from teleflex arrow international sales representative: i did complete the two additional complaints last week and expect that she will send out the acknowledgments and shipping labels shortly.I don¿t know if she is off this week, but i will check as i usually hear from her very quickly.With regard to the kit, our internal review has provided some interesting findings that were brought to my attention.First, the 20g catheter-over-needle in the kit is actually identified in the ifu as an introducer and not as an indwelling catheter.For this reason, the kit was labeled as an arterial access kit (rather than arterial catheter kit), meaning that the components are used to gain access for an additional catheter of the inserter¿s choosing that will stay with the patient.I don¿t think anyone (me included) realized this.The catheter in the kit is not the same design as the arterial catheter (as shown by the pictures you sent) and is not tested to the requirements of an arterial catheter.In the next few days i am expecting to receive a non-sterile kit prototype in which the original catheter-over-needle is replaced by one that is indicated for arterial use.I will bring it to dr.To review when i receive it.He is copied on the email so he can be aware of what is going on and what has been discussed thus far.Also copying, as she had reached out to me about this separately.We believe this change will address the issues with the kit.In the meantime, we should notify the inserters of the need to place an additional catheter when using this kit.

Event Description

Patient found to be bleeding from right radial arterial line, saturating pillow hand was on.Dressing taken down to be changed when significant amount of blood squirting out from the area of the catheter closest to the line attached.Occluded with gauze and arterial line removed.This has happened on 6 occasions in the last 2 months.4 of the catheters were sent to teleflex arrow international for investigation.Manufacturer response for arrow arterial access kit ask-04001-bid2, arterial access kit ask-04001-bid2 (per site reporter): email from teleflex arrow international sales representative: i did complete the two additional complaints last week and expect that she will send out the acknowledgments and shipping labels shortly.I don¿t know if she is off this week, but i will check as i usually hear from her very quickly.With regard to the kit, our internal review has provided some interesting findings that were brought to my attention.First, the 20g catheter-over-needle in the kit is actually identified in the ifu as an introducer and not as an indwelling catheter.For this reason, the kit was labeled as an arterial access kit (rather than arterial catheter kit), meaning that the components are used to gain access for an additional catheter of the inserter¿s choosing that will stay with the patient.I don¿t think anyone (me included) realized this.The catheter in the kit is not the same design as the arterial catheter (as shown by the pictures you sent) and is not tested to the requirements of an arterial catheter.In the next few days i am expecting to receive a non-sterile kit prototype in which the original catheter-over-needle is replaced by one that is indicated for arterial use.I will bring it to dr.To review when i receive it.He is copied on the email so he can be aware of what is going on and what has been discussed thus far.Also copying, as she had reached out to me about this separately.We believe this change will address the issues with the kit.In the meantime, we should notify the inserters of the need to place an additional catheter when using this kit.

• Brand Name: ARROW
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 13771764
• MDR Text Key: 287209973
• Report Number: 13771764
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN037314
• Device Catalogue Number: ASK-04001-BID2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1