MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SLIC COMPONENT: 7 FR X 8"; ACCESSORIES, CATHETER

Catalog Number SC-14701

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "the issue that occurred was the l-lock mechanism on the slic broke and then slic no longer had anything holding it within the introducer, and it did come dislodged from the patient with medications infusing".There was no patient harm or injury.The issue was resolved by infusing the medications to a different access point.Additional information received states that the current patient status is "deceased, unrelated to product issue".

Event Description

It was reported that "the issue that occurred was the l-lock mechanism on the slic broke and then slic no longer had anything holding it within the introducer, and it did come dislodged from the patient with medications infusing".There was no patient harm or injury.The issue was resolved by infusing the medications to a different access point.Additional information received states that the current patient status is "deceased, unrelated to product issue".

Manufacturer Narrative

(b)(4).The complaint of slic/sheath hub connection not secure was able to be confirmed by the photo as it revealed that the slic catheter hub was broken during use.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: SLIC COMPONENT: 7 FR X 8"
• Type of Device: ACCESSORIES, CATHETER
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18388730
• MDR Text Key: 331497705
• Report Number: 9680794-2023-01013
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K781846
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SC-14701
• Device Lot Number: 14F23H0185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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