MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI PICC KIT: 2-L 5 FR X 50 CM; PERIPHERALLY INSERTED CATHETER PRODU

Catalog Number CDC-35052-HPK1A

Device Problems Kinked (1339); Deformation Due to Compressive Stress (2889)

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

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.

Event Description

It was reported that when attempting to dilate the patient's skin, the peel away sheath "kinks on itself".As a result, a new kit was opened and used without issue.No additional information will follow.

• Brand Name: PI PICC KIT: 2-L 5 FR X 50 CM
• Type of Device: PERIPHERALLY INSERTED CATHETER PRODU
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5813296
• MDR Text Key: 50182378
• Report Number: 1036844-2016-00431
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: CDC-35052-HPK1A
• Device Lot Number: 23F16D0570
• Other Device ID Number: 00801902072603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• 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