MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER, PERCUTANEOUS

Catalog Number CV-12703

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the middle line is blocked.A new device was inserted.

Manufacturer Narrative

(b)(4).The customer returned the product lidstock and one 3-lumen cvc catheter for evaluation.The catheter showed evidence of use in the form of dried blood on the body and luer hubs.Visual examination of the catheter did not reveal any defects or anomalies.After decontamination, dried blood was observed in the catheter skive marks and in the proximal extension line.Each extension line was flushed using a lab inventory 10ml syringe filled with water.The distal extension line was able to be flushed with minimal resistance to the flow.The medial extension line had significant resistance to the flow when initially flushed.The dried blood around the skive mark was removed and greater force was applied to the syringe plunger which caused the blockage to break.Dried blood was observed to have come out of the skive mark and the extension line was able to be flushed with minimal resistance.The proximal extension line had no flow when initially flushed.Cleaning the skive hole and applying more pressure did not clear the line.The blockage was determined to be at the juncture hub by running a wire from either end of the extension line.A rigid metal wire was run through the juncture hub in an attempt to clear any dried blood occlusion.(con't) other remarks: dried blood was observed coming out of the proximal skive mark and the line was flushed again with water.After the dried blood had been removed, the proximal line was able to be flushed with minimal resistance.Therefore, the blockages observed during functional testing were a result of dried blood occlusions and not manufacturing related defects.A 0.032" guide wire was passed through the distal extension line with minimal resistance.A device history record (dhr) review was performed on the catheter and no relevant manufacturing issues were identified.The instructions for use (ifu) provided with this kit instructs the user to prepare the catheter for insertion by flushing each lumen and clamping or attaching injection caps to appropriate extension lines.Any blockage prior to use would be identified prior to insertion.The ifu also cautions the user that indwelling catheters should be routinely inspected for desired flow rate, security of dressing, correct catheter position and for secure luer-lock connection.The customer report of a blockage in the catheter was confirmed through functional testing of the returned sample.The medial extension line was returned partially occluded and the proximal extension line was returned fully occluded.Removing dried blood from the extension lines allowed for each line to be flushed with minimal resistance; therefore, the blockages observed during functional testing were a result of dried blood occlusions and not manufacturing related defects.The ifu provided with this kit instructs the user to flush each extension line prior to use which would identify any manufacturing related occlusions prior to insertion.Based on the evidence of use observed on the catheter and the results of the functional testing, the probable cause was determined to be operational context which either resulted in or contributed to the defect.

Event Description

The customer alleges that the middle line is blocked.A new device was inserted.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• 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: 6764645
• MDR Text Key: 81749702
• Report Number: 3006425876-2017-00250
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/20/2017

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: 12/31/2021
• Device Catalogue Number: CV-12703
• Device Lot Number: 71F17D1043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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