MAUDE Adverse Event Report: I-FLOW CORPORATION ON-Q PAINBUSTER; PUMP, INFUSION, ELASTOMERIC

Model Number SILVERSOAKER

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Material Protrusion/Extrusion (2979)

Patient Problems Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Reaction (2414); Device Embedded In Tissue or Plaque (3165)

Event Date 11/22/2013

Event Type  malfunction  

Event Description

The patient underwent a decompressive laminectomy and fusion for a grade 2 spondylolisthesis at l5-s1.On-q anesthetic catheters were placed bilaterally into the muscles.The physician did not encounter any difficulties with the catheter insertion.The catheters were placed after the physician had closed/sutured the incision.The catheters were secured with tape.Two days post op, the physician wrote an order for the removal of the on-q pump and it was removed by a registered nurse.The rn who removed the catheters was experienced at removing on-q catheters, but reported that it is not a frequently performed task, and this is the first time she has removed two on-q catheters from a patient.The rn reported that tape was used to secure the catheter and a small portion of tape was adhered to the patient's incisional dressing.Because the rn was concerned that the tape may tear the thin incisional dressing if she pulled at the tape to remove it, she used a scissors to snip the tape.She does not recall the proximity of the catheter to where she made the cuts.She gently pulled at and removed both on-q catheters at the same time.She reported that there was no resistance encountered during the removal process.The rn did not observe any breakage of the catheter but she also did not compare the two catheters once removed to assure they were both the same length, etc.Six days post discharge, the patient noticed an itching and pain sensation at the incision site.The site was covered with a dressing.The patient's spouse observed that there was irritation at the site and noticed a small plastic object protruding out from the patient's skin, the spouse pushed on the object and pulled out an approximately 7" piece of catheter.The physician was contacted and noted that there was a superficial skin reaction.No signs of infection.Treated with prophylactic oral antibiotics.
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manufacturer response for on-q painbuster silversoaker, on-q painbuster (per site reporter).
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they are following up and have requested the catheter piece.

• Brand Name: ON-Q PAINBUSTER
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): I-FLOW CORPORATION; 20202 windrow drive; lake forest CA 92630
• MDR Report Key: 3567467
• MDR Text Key: 4056299
• Report Number: 3567467
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/03/2014

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: Nurse
• Device Model Number: SILVERSOAKER
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2014
• Event Location: Home
• Date Report to Manufacturer: 01/10/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 57