MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 5 FR X 8 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-25502

Device Problems Partial Blockage (1065); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion in anesthesia, the md was unable to "regurge" through the distal line.As a result, a new kit was opened and used to complete the procedure without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: it was reported that during insertion in anesthesia, the md was unable to "regurge" through the distal line, this issue was confirmed.One arrow 5 fr x 8 cm catheter was returned.Dried blood / biological material was observed in the extension lines.Water was injected into both lumens using a 10 ml syringe.The distal lumen was found to be blocked.A gage wire (.018" diameter) was inserted into the distal lumen and the blockage was found to be in the area of the juncture hub.Normal flow was observed through the proximal lumen.The sample was soaked in hot water for one hour.After soaking, the gage wire was inserted into the distal extension line.After several attempts, the gage wire was pushed through the distal lumen.Only dried blood / biological material was observed exiting the lumen.After the blockage was removed, the.018 gage wire passed freely through the lumen.The instruction booklet directs the user to prepare the catheter for insertion by flushing and clamping each lumen.No blockage was reported before insertion.The ifu also states that indwelling catheters should be routinely inspected for desired flow rate.A device history record review was performed and did not other remarks: reveal any manufacturing related issues.Since the blockage was determined to be dried blood / biological material, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: CVC SET: 2-LUMEN 5 FR X 8 CM
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• 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: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6045518
• MDR Text Key: 58027884
• Report Number: 3006425876-2016-00331
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

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: 12/31/2016
• Device Catalogue Number: CS-25502
• Device Lot Number: 71F15E0786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2015
• 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