MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number IPN030863

Device Problems Obstruction of Flow (2423); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports difficulty in collecting a sample from the distal line.The reflow was very difficult via the distal line.It was observed that 2 lines (proximal and distal) were kinked and stuck on the internal side of the bandage.The lines were cut.The cut lines were clamped, the device was removed, and new device inserted.

Event Description

The customer reports difficulty in collecting a sample from the distal line.The reflow was very difficult via the distal line.It was observed that 2 lines (proximal and distal) were kinked and stuck on the internal side of the bandage.The lines were cut.The cut lines were clamped, the device was removed, and new device inserted.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cvc catheter for evaluation.Visual examination revealed the distal and proximal extension lines had been cut.All four points of separation were smooth, consistent to when the lines come in contact with sharps such as scissors or scalpel.The two sections of the returned distal extension line measured 41mm and 47mm totaling 88mm which is within specifications of 75-95mm per catheter product drawing.The outer diameter of the distal extension line measured 2.15mm which is within specification of 2.13-2.21mm per distal extension line extrusion product drawing.The inner diameter of the distal extension line measured 1.49mm which is within specification of 1.42-1.50mm per distal extension line extrusion product drawing.The two sections of the returned proximal extension line measured 27mm and 99mm totaling 126mm which is within specifications of 120-140mm per catheter product drawing.The outer diameter of the proximal extension line measured 2.18mm which is within specification of 2.13-2.21mm per proximal extension line extrusion product drawing.The inner diameter of the proximal extension line measured 1.49mm which is within specification of 1.42-1.50mm per proximal extension line extrusion product drawing.Both the distal and proximal extension lines were flushed proximal to the separation point and no blockage was found.A spring wire guide was inserted into both the distal and proximal extension lines distal to the separation point and passed through the catheter body confirming there was no blockage present.The medial extension line was flushed and no issues were found.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Do not cut catheter to alter length." the complaint description explicitly states, "the lines were cut" so an in-service request was made.The customer report of an extension line separation was confirmed by complaint investigation of the returned sample.The distal and proximal extension lines where both separated in the middle of the extension line body.The points of separation on the extension lines appeared smooth, indicating that the extension line became in contact with sharps such as scissors or a scalpel.The complaint description explicitly states, "the lines were cut" when the ifu provided with the kit warns the user, "do not cut catheter to alter length." therefore an in-service request was made.A device history record review was performed with no relevant findings.Based on the appearance of the damage and the customer report that it was identified during use, intentional use error caused or contributed to the reported event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9430509
• MDR Text Key: 179265930
• Report Number: 3006425876-2019-01035
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: IPN030863
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F19G0405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 47