MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 30CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number JP-14703-C

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the catheter flow was not so smooth.It is slightly/likely blocked, but not completely blocked.The catheter was inserted on august 28 and removed on october 3.

Event Description

The customer reports that the catheter flow was not so smooth.It is slightly/likely blocked, but not completely blocked.The catheter was inserted on (b)(6) and removed on (b)(6).

Manufacturer Narrative

Qn#(b)(4).The customer returned one cvc catheter.The catheter showed signs of use with dried blood in the catheter body and sutures attached to the box clamp.Visual inspection revealed stress marks in all three extension lines from being clamped.No other defects or anomalies were found.The catheter body measured 317mm in length which is within product specifications of 307-327mm per catheter drawing.The outer diameter of the catheter body measured 2.48mm which is within specifications of 2.39-2.49mm per catheter body extrusion graphic.A 0.032" diameter spring wire guide was inserted into distal extension line to functionally test the catheter for blockages.The wire guide passed through with minimal resistance.All three extension lines were flushed with water using a 10ml lab inventory syringe and functioned with no issues.A device history record review was performed and no relevant findings were found.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested." the customer reported issue of a catheter blockage was unable to be found during sample investigation.All three extension lines were able to be flushed with no issues.A wire guide was able to be passed through the distal extension line with minimal resistance.Visual and dimensional inspections were performed and no issues were identified.A device history record review was performed and no relevant findings were identified.Based on the inspection, no problem was found with the returned sample.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 30CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9540175
• MDR Text Key: 179716122
• Report Number: 3006425876-2020-00023
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/04/2024
• Device Catalogue Number: JP-14703-C
• Device Lot Number: 71F19A2520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1