MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 2-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-17702-KR

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is not sold in the us.A similar device is sold in the us.

Event Description

The customer alleges that when aspirating blood using the ars (arrow raulerson syringe), air was aspirated in the syringe.Another ars was used and the procedure continued without issue.

Manufacturer Narrative

(b)(4).The customer returned an 18ga x 2-1/2" introducer catheter from a catheter over needle and a 2-lumen catheter marked 7fr x 20cm on the catheter hub.Both catheters appeared typical.The syringe involved in this event was not manufactured by arrow and was returned to the manufacturer for analysis.The 7fr x 20cm catheter was leak tested at 45 psi for 30 sec.No crossovers or leaks were found in either lumen.A 10 ml syringe from lab inventory was used to aspirate water through each lumen with no indication of a leak.The 10ml syringe was used to inject water into the introducer catheter over needle while the distal end was occluded.No leaks were observed.The 10ml syringe was used to aspirate water through the introducer catheter over needle with no indication of a leak.A review of the dhr for the 2-lumen catheter did not reveal any manufacturing related issues.The report that air was aspirated into the syringe while checking catheter placement could not be confirmed through evaluation of the returned sample.An arrow catheter was returned and it passed leak and functional testing.The syringe involved in the event was not manufactured by arrow and was returned to the original manufacturer.No problem was found on the returned arrow catheter.

Event Description

The customer alleges that when aspirating blood using the ars (arrow raulerson syringe), air was aspirated in the syringe.Another ars was used and the procedure continued without issue.

• Brand Name: ARROW CVC KIT: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 6407117
• MDR Text Key: 70065308
• Report Number: 3006425876-2017-00095
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/01/2017

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: No Information
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: ASK-17702-KR
• Device Lot Number: 71F16F1376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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