MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7FR X 20CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number JP-17702-C

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

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 in the icu, a flushing test was performed prior to insertion of the catheter and no problem was confirmed at that time.The catheter was inserted into the patient, and after, the patient was moved to the icu.It was there that the md found a blood backward flow occurring at the extension line of proximal lumen.As a result, the catheter was removed and replaced with a new one.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 there that the m.D.Found a blood backward flow occurring at the extension line of proximal lumen this issue was not confirmed.One 7 fr x 20cm 2-lumen catheter was returned.The catheter body was cut off below the proximal skive - approximately 4 cm from the distal tip.Dried blood was observed in the proximal extension line.The catheter showed evidence of use but no defects or anomalies were observed during visual examination at 10x magnification.The catheter was leak tested.With the opposite end of each lumen occluded, water was injected into each extension line.Each lumen was pressurized to 45psi for 30 seconds.No leaks or cross-overs were observed.Since the catheter body was cut off below the proximal skive hole, the leak test is considered to be representative of the proximal lumen during use.A device history record review was performed and did not reveal any manufacturing related issues.No leaks were detected in either lumen of the catheter.No problem was found on the sample.No further action will be taken.

• Brand Name: CVC SET: 2-LUMEN 7FR X 20CM
• 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: 6215428
• MDR Text Key: 63627398
• Report Number: 3006425876-2016-00420
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: JP-17702-C
• Device Lot Number: 71F15J0520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2015
• 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