MAUDE Adverse Event Report: I-FLOW LLC ON-Q PAINBUSTER: SILVER SOAKER 5 IN: 400 ML, 5 ML/HR

Model Number PM026-A

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2014

Event Type  malfunction  

Event Description

Fill volume, flow rate: not applicable.Procedure: spine surgery.Cathplace: asked but not provided.It was reported that after spinal surgery a t-peel sheath broke off.The physician assistant was peeling off the t-peel sheath and twisted off one side of the blue wing.He did not pull the sheath out before he peeled it, and the wing of the sheath broke off.The wing broke outside of the pt, but most of the t-peel was still in the pt.Physician assistant had to use an instrument to take the rest of the sheath out of the pt.No pt consequence and the sample was not available for return.

Manufacturer Narrative

The sheath was not available for return.A device history review was conducted for the lot number reported (0201440433), which belongs to a kit for model pm026-a.The subcomponent lot number for the reported sheath.As a device was not available for an eval, no methods were performed; results cannot be obtained.Based on the reported info the sheath was not completely removed before peeling.Should additional info be received i-flow will submit a follow-up report.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for additional investigations.

• Brand Name: ON-Q PAINBUSTER: SILVER SOAKER 5 IN: 400 ML, 5 ML/HR
• Manufacturer (Section D): I-FLOW LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4098944
• MDR Text Key: 4700352
• Report Number: 2026095-2014-00168
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: PM026-A
• Device Catalogue Number: 70125843
• Device Lot Number: 00000024606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• 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: Initial
• Patient Sequence Number: 1