MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM; CATHETER, PERCUTANEOUS

Model Number IPN038325

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the catheter could not be clamped properly.

Event Description

The customer reports that the catheter could not be clamped properly.

Manufacturer Narrative

Qn#(b)(4).The customer returned one 2-lumen catheter for evaluation.The catheter contained obvious signs of use in the form of biological material.Sutures were attached to the rotating hub and catheter body.Visual examination of the catheter did not reveal any defects or anomalies.No cracks or damage were observed on the pinch clamps.The total length of the catheter body measured to be 266 mm which is within specifications of 257-277 mm per product drawing.The returned catheter was initially flushed using a lab inventory syringe to ensure no blockages were present.The extension line pinch clamps were then occluded and the extension lines were again flushed with a water-filled lab inventory syringe.No leaks passed through the occluded pinch clamps.Both extension line pinch clamps were able to be securely clamped and unclamped.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "the practitioner must be aware of potential air embolism/hemorrhage associated with large-bore catheters.Do not leave open needles or catheters in central venous puncture sites.To lessen the risk of disconnects, only securely tightened luer-lock connections should be used with this device.It is recommended that the extension lines be kept clamped at all times when not in use because of the catheter's large lumens.Follow hospital protocol to guard against air embolism/hemorrhage for all catheter maintenance." the customer report of pinch clamps not occluding could not be confirmed by complaint investigation of the returned sample.The returned catheter passed all relevant visual, dimensional, and functional testing, and a device history record review was performed with no relevant findings.The extension line pinch clamps on the returned device were able to be secured and functioned as expected.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10244802
• MDR Text Key: 198543194
• Report Number: 3006425876-2020-00610
• Device Sequence Number: 1
• Product Code: DQY
• 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: 06/25/2020

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: 09/14/2021
• Device Model Number: IPN038325
• Device Catalogue Number: CS-26122-F
• Device Lot Number: 71F20A1223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1