MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number CS-25703-E

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the initial triage of the returned device appears to have been in use at the time of the reported event.A follow up report will be submitted at the conclusion of the device investigation.

Event Description

Customer complaint alleges "the doctor was proceeding according to ifu to insert the cvc.However, the syringe and needle were not combined and could not be used." there was no patient involvement reported.There was no report of patient injury or consequence.

Manufacturer Narrative

(b)(4).The customer returned a cs-25703-e kit with multiple components for evaluation.The introducer needle was used for this investigation.No syringe was returned.Visual and microscopic examination of the needle revealed a crack in the introducer needle hub.The needle hub also contained signs of use in the form of dried blood.The needle hub was tested for leaks by attaching a lab ars syringe filled with water to the needle hub and then depressing the plunger to expel the water.Water exited the needle bevel but was also squirting from the crack in the needle hub.In addition, water was not able to aspirate into the syringe while the introducer needle was attached.This was likely due to the crack in the needle hub.A device history record review was performed on the needle and no relevant manufacturing issues were identified.The reported complaint that the introducer needle could not be used was confirmed by complaint investigation.The returned introducer needle hub contained a crack.A device history record review was performed and no relevant manufacturing issues were identified.Further investigation of this issue is being conducted under a capa (corrective action not yet implemented).The capa failure investigation indicates that the probable cause is design related.

Event Description

Customer complaint alleges "the doctor was proceeding according to ifu to insert the cvc.However, the syringe and needle were not combined and could not be used." there was no patient involvement reported.There was no report of patient injury or consequence.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• 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 ; 9194334854
• MDR Report Key: 7647540
• MDR Text Key: 112847494
• Report Number: 3006425876-2018-00434
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/23/2019
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F17M0868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• 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