MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-25853-E

Device Problems Break (1069); Material Separation (1562)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer reports that the needle broke during use.The doctor used the other side for insertion and another device and the procedure was successful.

Manufacturer Narrative

(b)(4).Lot# corrected to 71f16m0366.The customer returned a catheter-over-needle assembly with the needle inserted into the catheter.Both components from the catheter- over-needle assembly were examined microscopically and appeared normal.No obvious defects were observed on the needle hub, needle cannula, or catheter.A leak test was performed on the needle by occluding the proximal needle tip and pressurizing the needle with water using a lab inventory 10ml syringe.No leaks were observed.Water was aspirated through the returned needle using a lab inventory 10ml syringe and no obvious defects were observed.No difference was observed when compared to an aspiration performed using a stock inventory introducer needle of the same part number.A device history record (dhr) review was performed and no relevant findings were identified.The report of a broken needle hub could not be confirmed through visual and functional testing of the returned sample.No obvious defects were visible on the returned components and no leaks were observed during functional testing of the needle.No problem was found on the returned sample.

Event Description

The customer reports that the needle broke during use.The doctor used the other side for insertion and another device and the procedure was successful.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 6411190
• MDR Text Key: 70176629
• Report Number: 3006425876-2017-00098
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

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 Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: CS-25853-E
• Device Lot Number: 71F16M0366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• 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