MAUDE Adverse Event Report: ARROW INTL., INC. PICC SET: 2-L 16 GA X 19-1/2" (50 C; PERIPHERALLY INSERTED CATHETER PRODU

Catalog Number PS-01652

Device Problems Wrinkled (2614); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

It was reported that in the icu, the user was only able to advance the catheter 5 centimeters.The user made three attempts at insertion but was unable to advance the catheter more than 5 cm each attempt.This caused the tip of the catheter to accordion.The guide wire was successfully inserted into the patient's left arm however the catheter was replaced.A delay was reported, however, there was no additional reported harm to the patient due to this delay or as a result of this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: PICC SET: 2-L 16 GA X 19-1/2" (50 C
• Type of Device: PERIPHERALLY INSERTED CATHETER PRODU
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: john george, specialist ; 2400 bernville rd.; reading, PA 19605
• MDR Report Key: 4488368
• MDR Text Key: 5562163
• Report Number: 1036844-2015-00048
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K042126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: PS-01652
• Device Lot Number: 23F14K1411
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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
• Patient Age: 20 YR