MAUDE Adverse Event Report: HALYARD-IRVINE ON-Q CATHETER SILVER SOAKER 2.5IN (6.5CM)

Model Number PM010-A

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

Patient Problem Reaction (2414)

Event Date 03/10/2015

Event Type  Injury  

Event Description

Please reference: 2026095-2015-00120/15-00259.Procedure: c-section ((b)(6) 2015).Cathplace: abdomen.Report #2 of 2: it was reported that an incident of a reaction occurred with the use of a pump and dual catheter.It was reported that a post-partum patient went to the emergency department (ed) on (b)(6) 2015.The ed doctor examined the patient for infection, noted that the catheter was yellow and ordered antibiotics.The patient took one dose of the antibiotics and then followed-up with the surgeon.The surgeon assessed the patient¿s catheter site; the patient had no signs and symptoms of infection, no pain or redness to area.The surgeon ordered the patient to stop taking antibiotics, as the surgeon assessed that there was no signs of infection; the catheter's reported yellow color being due to antimicrobial characteristics.At this point, the pump had been connected to the patient for 5-days.Additional information was received on (b)(6) 2015.It was reported that the patient removed the pump and catheter on (b)(6) 2015 at approximately 1100.The patient reported that there were no signs and symptoms of infection (no pain, fever or redness, at the site).Additional information was received on (b)(6) 2015.It was reported that the patient took a photograph of the catheter site after removing the tegaderm and before removing the catheter.The photograph indicated that the area appeared red.Upon receiving the report of redness, the doctor restarted the patient on antibiotics for potential infection.It was clarified that the patient had initially gone to the ed due to pain and unspecified issues with oral opiates.

Manufacturer Narrative

Pt age: patient's exact age was not reported.It was reported that the age was approximately (b)(6) years old.(b)(4).Method: the device was received for analysis.A visual inspection was performed.The reporter was unable to provide a lot number; thus, the review of the device history record (dhr) cannot be conducted.Results: there are no testing results available as the investigation and evaluation are currently in progress.Conclusions: once the analysis and investigation are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Manufacturer Narrative

Methods: along with the other method previously reported, a microscopic inspection and a use review were performed.Results: a visual and microscopic inspection was performed on the silversoaker catheters and did not find any deformation.However, the devices are deemed unable to be evaluated for the reported incident, as a culture was not conducted at the time of the incident.Per the instructions for use (ifu)(14-60-602-0-04) : "on-q* silversoaker* contains an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter.The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised.The antimicrobial agent is not intended to be used as a treatment for existing infections.The antimicrobial effects of silversoaker* catheters has been shown to be active for up to 10 days.Remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter." conclusions: the complaint is deemed as unable to be evaluated.A culture was not performed at the time of the incident.It was reported that the pump was disconnected to assess if it was flowing.The doctor did not observe the end of the tubing beading with the clamp opened; however, the doctor reconnected the pump to the patient.Per the use review, the closed infusion barrier was broken when the pump was disconnected from the catheter; which may have increased the risk of possible contamination.It is possible user/facility conditions contributed to the reported event.In addition, the ifu cautions "¿ product is ethylene oxide sterilized.¿ do not use if package has been opened or is damaged.¿ single use only.Do not resterilize or reuse.Reuse of the device could result in the following risk: ¿ damage to the catheter and introducer.¿ increased risk of infection.¿ maintain catheter per standard hospital protocol." however, the assignable cause cannot be determined for the reported incident.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-Q CATHETER SILVER SOAKER 2.5IN (6.5CM)
• Type of Device: CATHETER
• Manufacturer (Section D): HALYARD-IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4650125
• MDR Text Key: 5616139
• Report Number: 2026095-2015-00121
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PM010-A
• Device Catalogue Number: 101353300
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 04/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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: TAGADERM; UNSPECIFIED ORAL OPIATES; MARCAINE 0.5%
• Patient Outcome(s): Other