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

Model Number IPN030863

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "the medium line of the catheter slipped from its attachment while the bandage was removed.The central line was no longer in the right position in the jugular vein because the catheter gradually moved." the central line was replaced.Additional information was requested on the patient's condition, but was not available at the time of this report.

Event Description

The complaint is reported as: "the medium line of the catheter slipped from its attachment while the bandage was removed.The central line was no longer in the right position in the jugular vein because the catheter gradually moved." the central line was replaced.Additional information was requested on the patient's condition, but was not available at the time of this report.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cvc for analysis.The catheter contained obvious signs of use in the form of biological material.All three lumens appeared to be intentionally cut and the box clamp was returned attached to the catheter body.Visual analysis of the returned catheter, clamp fastener, and the clamp catheter did not reveal any defects or anomalies.There is no evidence to suggest that the catheter suture wings were also secured with sutures.The outer diameter of the returned catheter body measured to be 2.89 mm which is within specifications of 2.85-2.95 mm per product drawing.The inner diameter of the clamp catheter measured to be 2.88 mm which is within specifications of 2.74-2.95 mm per product drawing.The catheter clamp and fastener were attached to the returned catheter body.The box clamp assembly was held stationary and the catheter was tugged on in both directions.Moderate movement was identified.The suture wings of the juncture hubs were then held stationary and the catheters were tugged on in both directions.No movement was identified.The ifu provided with this kit instructs the user, "use a catheter stabilization device, catheter clamp and fastener, staples or sutures (where provided).Use triangular juncture hub with side wings as primary suture site.Use catheter clamp and fastener as a secondary suture site as necessary".The customer report of a catheter migration was confirmed by functional testing of the returned sample.The catheter moved when secured by only the box clamp, but passed testing when secured by the juncture hub suture wings.The primary suture location for this catheter is the juncture hub using the triangular wings.It could not be determined if the box clamp was used as the primary or secondary suture site; therefore, the probable cause could not be determined.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: 11853050
• MDR Text Key: 251746308
• Report Number: 3006425876-2021-00428
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902000559
• UDI-Public: 10801902000559
• 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: 04/29/2021

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 Model Number: IPN030863
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F20K1371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.