MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER, HEMODIALYSIS, NON-I

Model Number IPN030883

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Customer reported that when the nurse in charge of removing the dressing covering the catheter, she noticed that the arterial extension line (red) was disconnected from the catheter.

Manufacturer Narrative

(b)(4).The customer returned a 2-l hemodialysis catheter for evaluation.Visual inspection revealed the proximal extension line has separated at the connection point where the wire attaches the two portions of the extension line.The wire serves as a connection point between the two parts of the extension line and is connected inside a cavity molded within the connection hub.Damage to the wire assembly and the cavity were observed, and it was evident the wire had previously been molded within the cavity (as with the distal extension line).Based on the damage to the wire, the extension line and the connection point, the separation is consistent with an undue force being applied to the extension line.No other defects were found.The distal extension line was undamaged with the wire connecting the extension line portions securely.The overall length of the catheter body measured 214mm which is within specification of 207-227mm per product drawing.The outer diameter of the wire assembly measured 5.20mm which is consistent with the nominal of 5.21mm per product drawing.A tug test was applied to the distal line.The distal connection point stayed intact.A dhr review was completed with no relevant findings.The ifu provided with this kit warns the user "the extension lines of you-bend are not to be reformed on a continuous basis.Excessive re-forming of the extensions may lead to wire fatigue and breakage." the customer complaint of the extension line separated was confirmed through this investigation.The proximal wire/extension assembly was found to be separated at the connection point in the extension line.The wire was observed to be damaged and the point of separation was rough and jagged which is consistent with an undue force being applied to the extension line body.A dhr review was completed with no relevant findings and the returned device passed all relevant dimensional specifications.Based on the sample received and the appearance of the damage, unintentional use error (undue force) caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Customer reported that when the nurse in charge of removing the dressing covering the catheter, she noticed that the arterial extension line (red) was disconnected from the catheter.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Type of Device: CATHETER, HEMODIALYSIS, NON-I
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9848586
• MDR Text Key: 184071481
• Report Number: 3006425876-2020-00243
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K991431
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: IPN030883
• Device Catalogue Number: CV-15142-UF
• Device Lot Number: 71F18K0549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1