MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN CVC KIT: 2-L 7 FR X 8" (20 C; CATHETER, PERCUTANEOUS

Catalog Number SA-17702-J

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter migrated from the patient's body while in use.By checking, the catheter box clamp was found detached.Therefore, the user replaced the catheter with a new one.No patient harm reported.The patient's condition is reported as fine.

Event Description

It was reported that the catheter migrated from the patient's body while in use.By checking, the catheter box clamp was found detached.Therefore, the user replaced the catheter with a new one.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one clamp catheter and clamp fastener for investigation.Visual examination of the clamp catheter and clamp fastener did not reveal any defects or anomalies.Visual inspection of the catheter could not be performed as it was not returned for investigation.The inner diameter of the clamp catheter measured to be 0.092" (2.336 mm) which is within specifications of 2.240-2.340 mm per product drawing.The inner diameter of the clamp fastener measured to be 0.178" (4.52 mm) which is within specifications of 4.32-4.57 mm per product drawing.Functional inspection was performed per the product instructions-for-use.The ifu states the following: "secure catheter to patient.Use triangular juncture hub with integral suture ring and side wings as primary suture site.In kits where provided, the catheter clamp and fastener should be utilized as a secondary suture site as necessary." the returned clamp catheter and clamp fastener were attached to a lab inventory catheter.The box clamp assembly was held stationary, and the catheter was pulled in both directions.The box clamp did not shift position on the catheter body and the catheter was not able to migrate.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit instructs the user, "secure catheter to patient.Use triangular juncture hub with integral suture ring and side wings as primary suture site.In kits where provided , the catheter clamp and fastener should be utilized as a secondary suture site as necessary." the customer report of a catheter migration could not be confirmed by complaint investigation of the returned sample.No defects or anomalies were observed with the returned catheter clamp and catheter fastener.A device history record review was performed with no relevant findings.Upon functional testing, the box clamp assembly did not shift position on the lab inventory catheter body and the catheter was not able to migrate.Additionally, the primary suture location for the catheter is the juncture hub using the triangular wings.Since the catheter was not returned, a full complaint verification could not be performed.Additionally, it could not be determined if the box clamp was used as the primary or secondary suture site.Therefore, the probable root cause could not be determined based on the sample received, the information available, and without the actual catheter to evaluate.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW MULTI-LUMEN CVC KIT: 2-L 7 FR X 8" (20 C
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12640855
• MDR Text Key: 276683360
• Report Number: 3006425876-2021-00952
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: SA-17702-J
• Device Lot Number: 71F21B1252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• 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