MAUDE Adverse Event Report: I-FLOW, LLC ON-Q PAINBUSTER: SOAKER 5IN, 270ML, DUAL 2+2ML/HR; CATHETER, CONDUCTION, ANESTHETIC

Model Number PM025

Device Problems Stretched (1601); Split (2537)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/28/2014

Event Type  malfunction  

Event Description

Fill volume: not applicable.Flow rate: not applicable.Procedure: colon surgery.Cathplace: fascia plain (abdomen).A catheter break was reported to our sales rep.The pt had colon surgery on (b)(6) 2014.During removal of the catheter, a 4 to 5 inch piece of catheter broke and retained inside the pt.An x-ray was taken, but the catheter remnant was not noted.The pt was reported as stable.No other intervention is known at this time.Additional info received (b)(4) 2014.Some resistance was met when removing the catheter.It is unk how much resistance, but the catheter sample appears to be stretched.The catheter segment that was obtained shows the 1st black marking.Most likely, about 2 1/4 inches of the catheter was left inside the pt.The pt is doing well and release from the hospital.At this time there is no plan to remove the catheter remnant from the pt.

Manufacturer Narrative

Method: the device was returned for an eval and investigation.A visual inspection was performed on the returned device.A review of the device history record is in progress for the reported lot number.Results: results will be provided once the eval and investigation have been completed.Conclusions: our investigation and eval is currently in progress, once completed a follow-up report will be submitted.Info from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.

• Brand Name: ON-Q PAINBUSTER: SOAKER 5IN, 270ML, DUAL 2+2ML/HR
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3967155
• MDR Text Key: 4605642
• Report Number: 2026095-2014-00101
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM025
• Device Catalogue Number: 101364000
• Device Lot Number: 0201054727
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 39 YR
• Patient Weight: 61