MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number CDC-41541-MPKB

Device Problems Material Separation (1562); Material Twisted/Bent (2981); Material Too Soft/Flexible (4007)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: glide thru peel away sheath broke at the handle, on the proximal portion of the sheath.The material felt thinner and softer on one side.The nurse used her fingers to carefully separate and peel away the remaining sheath body.She was able to complete the procedure.Additional information: the insertion site was upper arm.The patient skin was reported as tough.The peel away buckled at the tip leading into the skin.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and there was one potential finding.Without the sample returned, it cannot be confirmed if the failure mode of this complaint is the same as/relevant to the finding.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported that: glide thru peel away sheath broke at the handle, on the proximal portion of the sheath.The material felt thinner and softer on one side.The nurse used her fingers to carefully separate and peel away the remaining sheath body.She was able to complete the procedure.Additional information: the insertion site was upper arm.The patient skin was reported as tough.The peel away buckled at the tip leading into the skin.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17974986
• MDR Text Key: 326144555
• Report Number: 9680794-2023-00832
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 10801902205411
• UDI-Public: 10801902205411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDC-41541-MPKB
• Device Lot Number: 33F23C0191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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