MAUDE Adverse Event Report: I-FLOW, LLC PAINBUSTER SOAKER 2.5, 100ML, 2ML/HR; CATHETER CONDUCTION ANESTHETIC

Model Number PS2502

Device Problems Split (2537); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Fill volume: unk, flow rate: unk, procedure: abdominal surgery, cathplace: unk.The distributor reported an incident of a catheter break that occurred 12 months ago.The soaker was left in situ at the time, as the nurse removing the catheter did not observe that the catheter was incomplete upon removal.Subsequently the patient reported abdominal pain.The patient was not harmed but reported to have suffered pain for twelve months.When the patient went in for another procedure the catheter remnant was surgically removed using local anesthetic.

Manufacturer Narrative

Method: a portion of the catheter segment was returned for analysis.A visual inspection was performed on the suspect device.The lot number of the suspect device was unavailable, therefore, a review of the device history record (dhr) could not be performed.Results: at this time the suspect device is undergoing evaluation and testing.Results will be provided when evaluation has been completed.Conclusions: our investigation and evaluation is currently in progress, once 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: PAINBUSTER SOAKER 2.5, 100ML, 2ML/HR
• Type of Device: CATHETER CONDUCTION ANESTHETIC
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3893990
• MDR Text Key: 4650613
• Report Number: 2026095-2014-00083
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PS2502
• Device Catalogue Number: 101343300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2014
• 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