MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 4-LUMEN 8.5FR X 30CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number DE-14854-S

Device Problem Split (2537)

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

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.

Event Description

It was reported that the event occurred intensive care unit 2.During insertion of the dilator into the right subclavian vein the tip of the dilator split.As a result a new kit was used successfully.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the tip of the dilator split was confirmed.Returned was an opened kit containing a dilator and other components.The dilator was bent 0.5" from the tip.The tip of the dilator was observed to be damaged with the unaided eye.Microscopic examination showed that the dilator tip was split in two locations.There were also two depressions on the body close to the tip.White marks were around one of the depressions, indicating that it had been exposed to stress.The id of the dilator tip could not be measured due to the damage to the tip.The instruction booklet provided with the kit describes an insertion procedure including the step to enlarge the cutaneous puncture site if necessary with the cutting edge of a scalpel prior to dilating.The customer did not report whether or not this was performed.A review of the device history records did not reveal any manufacturing related issues.Based on the appearance of the tip and the report that it occurred during insertion, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: CVC SET: 4-LUMEN 8.5FR X 30CM
• Type of Device: ADULT MULTI LUMEN 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: 6173177
• MDR Text Key: 62329000
• Report Number: 3006425876-2016-00390
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2016

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: 04/30/2018
• Device Catalogue Number: DE-14854-S
• Device Lot Number: 71F16E0951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• 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