MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB+; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-42703-PUKS1

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

During a resuscitation, a fem line 16cm cvc kit ask-42703-puks1 was being placed and when they were attempting to thread the wire, the wire would not advance out of the wire plastic housing.Upon inspection, they noted the wire was bent in the housing.The wire was not used on the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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

During a resuscitation, a fem line 16cm cvc kit ask-42703-puks1 was being placed and when they were attempting to thread the wire, the wire would not advance out of the wire plastic housing.Upon inspection, they noted the wire was bent in the housing.The wire was not used on the patient.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB+
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13429761
• MDR Text Key: 286069391
• Report Number: 9680794-2022-00057
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASK-42703-PUKS1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2022
• 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: N/A.; N/A.