MAUDE Adverse Event Report: I-FLOW, LLC ON-Q C-BLOC: 400ML, 2-14 ML/HR SELECT-A-FLOW; ELASTOMERIC PUMP

Model Number CB004

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

Drug/diluent: unk.Fill volume: unk.Flow rate: unk.Procedure: unk.Cathplace: unk.A pt returned a pump and claimed the pump had emptied in less than 24 hours.The physician reported: i got back a pump from a pt who had a femoral nerve catheter at sck that she claims emptied in less than 24 hours.She said it had a hole in it.She brought it in and it does appear to have a small hole in the outer bladder.I am not able to examine the inner one.An event date is not available at this time.Attempts have been made to obtain add'l info from the complainant on (b)(6) 2014.

Manufacturer Narrative

Method: at the time of this report, the sample has not yet been received, but was reported to be available for investigation and eval.The lot number was not provided; therefore the device history records (dhr) could not be reviewed.Results: at this time the investigation is still in progress.Results will be provided once completed.Conclusions: a follow up report will be filed when the investigation has been completed as it is currently in progress.Info from this incident will be included in our product complaint and mdr trend reporting system.Add'l investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.

• Brand Name: ON-Q C-BLOC: 400ML, 2-14 ML/HR SELECT-A-FLOW
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: marie wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3973021
• MDR Text Key: 4629279
• Report Number: 2026095-2014-00053
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: No
• 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