MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number CS-15853

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems High Blood Pressure/ Hypertension (1908); No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the little wings in the plastic sheared by the suture thread.The suture thread stayed on the skin of the patient.The catheter was found detached in the bed of the patient.The catheter was removed and replaced.The customer reports high blood pressure and no bleeding.

Manufacturer Narrative

(b)(4).The customer returned one catheter for investigation.Visual examination of the returned catheter revealed that both wings of the suture site on the juncture hub were severed.Microscopic examination of the point of separation revealed that the material is uneven and jagged.No pieces appear to be missing.No additional defects or anomalies were observed.The lot number was not reported by the customer; therefore, sales history records were reviewed for the most recent lot sold to the customer prior to the event.A device history record (dhr) review was performed on that lot number and there were no relevant findings.The instructions-for-use (ifu) that are packaged with this product suggest using the catheter clamp and fastener as secondary securement sites to mitigate the risk of catheter migration.The reported complaint of the migration of the catheter was confirmed through visual examination of the returned sample.Both suture wings were found to be torn.Visual examination of the point of separation revealed that the material appeared jagged and uneven as if the material was torn.A dhr review was performed based on sales history with no evidence to suggest a manufacturing related cause.Based upon the complaint report, which states, "the little wings in plastic were sheared by the suture thread," the torn suture wings caused the catheter to migrate.Based on that description and the type of damage observed, it was determined that operational context caused or contributed to this event.

Event Description

The customer reports that the little wings in the plastic sheared by the suture thread.The suture thread stayed on the skin of the patient.The catheter was found detached in the bed of the patient.The catheter was removed and replaced.The customer reports high blood pressure and no bleeding.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6947513
• MDR Text Key: 89727544
• Report Number: 3006425876-2017-00446
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CS-15853
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1