MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 16 GA X 20 CM; PERCUTANEOUS CATHER

Catalog Number ASK-04301-KR

Device Problem Occlusion Within Device (1423)

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

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device product is not sold in the us.However, similar product is sold in the us.

Event Description

The customer alleges that the flushing test of the device was performed prior to insertion of the catheter and no problem was confirmed at that time.However, after placement of the catheter, a catheter blockage was confirmed.The catheter was removed and no further treatment was necessary.

Manufacturer Narrative

(b)(4).The customer returned one single lumen cvc catheter.Visual examination of the returned catheter revealed signs of use but no damage or defects were observed.The catheter appeared used but typical.Microscopic examination revealed a nick in the extension line at the connection to the extension line hub.The nick and adhesive residue were observed in the same area indicating that this damage likely occurred upon removal of adhesive.Functional testing was performed by connecting a 10ml lab inventory syringe filled with water to the extension line hub.Pressure was applied to the syringe plunger and water was injected into the catheter and exited at the distal tip and at the extension line hub and tubing connection where the nick was observed.No resistance was encountered and no blocks were found.A 0.035 inch long pin gage was inserted into the extension line hub and passed through the body easily exiting at the distal tip.Again no resistance was met and no blocks were found.A device history record (dhr) review was performed on the ca theter and did not reveal any relevant findings.(con't) other remarks: the reported complaint of catheter blocked after insertion could not be confirmed through examination and functional testing of the returned sample.No resistance was met and no blocks were found during functional testing of the returned sample.A dhr review did not reveal any manufacturing related issues.No blockage related problem was found with the returned catheter.

Event Description

The customer alleges that the flushing test of the device was performed prior to insertion of the catheter and no problem was confirmed at that time.However, after placement of the catheter, a catheter blockage was confirmed.The catheter was removed and no further treatment was necessary.

• Brand Name: ARROW CVC KIT: 16 GA X 20 CM
• Type of Device: PERCUTANEOUS CATHER
• 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: 6230008
• MDR Text Key: 64074253
• Report Number: 3006425876-2017-00024
• 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: 12/22/2016

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: No Information
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: ASK-04301-KR
• Device Lot Number: 71F16A0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• 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