MAUDE Adverse Event Report: I-FLOW LLC PROLONG BLOCK BEVEL - 19 GA X 50MM; ELASTOMERIC PUMP

Model Number PL19100GC

Device Problems Kinked (1339); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

Fill volume: not applicable, flow rate: not applicable, procedure: unk, cathplace: unk.Please reference 2026095-2014-00175/(b)(4).Report 1 of 2.It was reported that on an unknown date, a catheter had broke.The physician was able to insertion the catheter through the needle with no problem.When the physician attempted to inject medication through the catheter, it would not go through.After several attempts without results, the catheter was removed from the patient.When it was removed, it was noted the catheter was kinked and sheared.The entire catheter was accounted for, so no pieces was left inside the patient.Additional information has been requested, but not yet available.

Manufacturer Narrative

Method: the device was received for an analysis and a visual inspection has been performed.At this time the device is undergoing testing.At this time a review of the device history review is in progress.Results: evaluation and investigation results will be provided once they are completed.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.Information from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend information, or other analysis as appropriate.

• Brand Name: PROLONG BLOCK BEVEL - 19 GA X 50MM
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4110266
• MDR Text Key: 21733896
• Report Number: 2026095-2014-00173
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: PL19100GC
• Device Catalogue Number: 103277100
• Device Lot Number: 0201188627
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Treatment: DRUG: NOT APPLICABLE