MAUDE Adverse Event Report: I-FLOW, LLC ON-Q PAINBUSTER: SILVERSOAKER 5IN: 400ML, DUAL 2+2; ELASTOMERIC PUMP

Model Number PM028-A

Device Problems Bent (1059); Stretched (1601); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2014

Event Type  Injury  

Event Description

Procedure: breast implant surgery.Cathplace: behind the implant at the chest.It was reported that a (b)(6)-year-old female patient under went breast implant surgery on (b)(6) 2014.Two catheters were inserted bilaterally behind the implants at the chest.On (b)(6) 2014, during catheter removal, one of the catheters broke and a part of the catheter was retained inside the patient.It was reported that no resistance was met during catheter removal, but it was reported that the catheter appeared stretched and bent when removed.The patient went for an x-ray and the catheter remnant was located under the x-ray.It was removed.The patient was reported to be stable with no adverse sequelae.

Manufacturer Narrative

Method: actual device was received for an analysis.A review of the device history record (dhr) was conducted for the lot number reported.Photographic images were provided by the reporter of the catheter.Results: at this time the evaluation is still in progress.Results will be provided once completed.The device history record (dhr) was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.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: ON-Q PAINBUSTER: SILVERSOAKER 5IN: 400ML, DUAL 2+2
• 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: 3954673
• MDR Text Key: 4622240
• Report Number: 2026095-2014-00122
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: PM028-A
• Device Catalogue Number: 101372100
• Device Lot Number: 0201114247
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 64