MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER, SUBCLAVIAN

Catalog Number CS-15122-F

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The results of the investigation are pending at the time of this report.

Event Description

The customer alleges that while in use, the catheter connector broke when connecting it to the dialysis tubing.

Manufacturer Narrative

(b)(4).No complaint sample was returned by the customer; however, the customer provided a photo displaying a hemodialysis set.A dimensional and functional inspection could not be performed as no sample was returned for analysis.Customer did not supply a lot number, however, a sales history review revealed potential lot numbers.A device history record review was performed on the catheter for the most likely batch number and no relevant findings were identified.The customer complaint indicated that the extension line luer hub was cracked.A photo was provided by the customer, however; no defect was verified based upon the photo received.The probable cause of the cracked luer hub could not be determined based upon the information provided and without a sample.No further action will be taken.Corrective action is not required at this time.The ifu provided with the set warns that indwelling catheters should be routinely inspected for desired flow rate, security of dressing, correct catheter position, and for secure luer-lock connection.It also states not to use acetone or alcohol with this catheter.Alcohol and acetone can weaken the structure of the catheter's material.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER, SUBCLAVIAN
• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 6588340
• MDR Text Key: 75870515
• Report Number: 3006425876-2017-00176
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-15122-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2017
• 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