MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. 26G (1.9F) 0.60MM X 30CM; L-CATH PICC

Catalog Number 384539

Device Problems Break (1069); Crack (1135); Leak/Splash (1354); Difficult to Remove (1528); Out-Of-Box Failure (2311)

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

Event Date 07/15/2014

Event Type  No Answer Provided  

Event Description

Original report this account has 2 lines infiltrate and break at the luer hub once placed and also, prior to using the catheter they have not been able to remove they piece causing the luer to crack at break (at the spin collar).Report was updated on (b)(6) 2014 with additional information indicating medical intervention: picc #1 - out of box failure, the y-port would not disconnect from picc (b)(4)) never in patient.Picc #1 - out of box failure, the y-port would not disconnect from picc (b)(4)) never in patient.Picc #3 - picc line successfully inserted.Picc leaking after few days of dwelling.Medical intervention - picc d/c'ed.(#(b)(4)) and picc #4 placed.Picc #4 - picc line placed successfully.Within 12 hours of insertion the picc infiltrated.Medical intervention picc d/c'ed (#(b)(4)).Picc #5 placed.Picc #5 - new picc placed successfully of different lot (b)(4)) picc still dwelling in patient without issue.

Manufacturer Narrative

A review of the device history record for the complaint lot showed that the product was manufactured according to specifications and documented procedures.The complaint device was not returned for evaluation.The two unopened picc's returned for evaluation/investigation were never in a patient; (b)(6)/lot #11064795 but were the same lot# that was identified as not meeting the customers expectations.A visual observation of the two returned unused catheter showed no abnormalities or defects.A leak/flow test and a pull test were performed per operating procedure.The catheters met the specifications.The root cause of the complaint could not be determined because the complaint device was not sent back for evaluation.Catheters are 100% inspected at various stages during the manufacturing process for any damage that may affect he performance of the product.A pressure test is performed on all catheters during manufacturing to ensure they can withstand the pressure and forces when utilized within the instructions for use.

• Brand Name: 26G (1.9F) 0.60MM X 30CM
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; athens TX
• Manufacturer Contact: gail smith ; 1445 flat creek rd.; athens, TX 75751 ; 9722102562
• MDR Report Key: 4040203
• MDR Text Key: 4805813
• Report Number: 1625425-2014-00025
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• 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: 384539
• Device Lot Number: 11064795
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1