MAUDE Adverse Event Report: I-FLOW, LLC ON-Q EXPANSION KIT: SILVER SOAKER 5IN (12.5CM); ON-Q CATHETER, ON-ANTIMICROBIAL CATH

Model Number PM020-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/10/2014

Event Type  Injury  

Event Description

Fill volume: not applicable.Flow rate: not applicable.Procedure: exploratory laparotomy, bilateral salpingo oophorectomy and lysis of adhesion.Cathplace: abdomen, pfannenstiel incision, with sub-fascial placement.{(b)(4)} (catheter) a nurse reported to an i-flow clinical specialist that a female pt had an infection post op on (b)(6) 2014.She underwent the above listed surgeries on (b)(6) 2014, wednesday.An on-q silversoaker was placed in her abdomen and connected to an on-q pump infusion bupivacaine to the surgery site.Dermabond was used at the catheter site and the catheter was secure on the skin with tegaderm dressing.As she is a larger pt, part of the catheter was in between her skin folds.On friday, (b)(6) 2014, this pump ran out, so a second pump model number p400x5 (pump 2) was connected to this catheter in the pt's hospital room.On the morning of (b)(6) 2014, when the second pump and the catheter were removed, the pt exhibited signs and symptoms of infection at the catheter site - the site was red and warm to touch with small amount of drainage oozing out.The pt had been under antibiotics treatment with clindamycin, vancomycin, and gentamycin started on (b)(6) 2014.On (b)(6) 2014.The antibiotics regimen was changed to vancomycin and zosyn.The pt was reported as recovering at the time of this report.The 1st pump was filled on (b)(6) 2014 in the am.The 2nd pump was filled on (b)(6) 2014 at 15:47, infusion ended approximately (b)(6) 2014 and both the pump and catheter were removed in the morning.The pump was empty at the time of disconnect.

Manufacturer Narrative

Method: a visual inspection was performed on the returned unit.Results: at this time the evaluation is still in progress.Results will be provided once completed.The lot met all manufacturing specifications at release.Conclusion: our investigation and evaluation 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 EXPANSION KIT: SILVER SOAKER 5IN (12.5CM)
• Type of Device: ON-Q CATHETER, ON-ANTIMICROBIAL CATH
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4006556
• MDR Text Key: 17993263
• Report Number: 2026095-2014-00113
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2014
• 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
• Treatment: BUPIVACAINE; PREMARIN 0.3MG; ZOLOFT 20MG; HYDROCHLORIDE (HCTZ); TEGADERM
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 98