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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q EXPANSION KIT SILVERSOAKER 2.5IN (6.5CM); CATHETER, CONDUCTION, ANESTHETIC

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HALYARD - IRVINE ON-Q EXPANSION KIT SILVERSOAKER 2.5IN (6.5CM); CATHETER, CONDUCTION, ANESTHETIC Back to Search Results
Model Number PM010-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 03/11/2015
Event Type  Injury  
Event Description
Please reference: 2026095-2015-00140/(b)(6) and 2026095-2015-00144/(b)(6).Procedure: c-section.Cathplace: right side of abdomen.Device 2 of 3: an incident of infection while using a pump and dual catheters was reported.The patient underwent a c-section surgery.The catheters were placed on the right side of the abdomen exiting approximately 2 inches away from the surgical site.The patient was discharged on (b)(6) 2015 with the pump and dual catheters.On (b)(6) 2015, the patient was readmitted to the hospital with fever and drainage from the surgical site.The patient was treated with iv vancomycin and ceftazidime at the hospital.The patient was discharged on (b)(6) 2015 with oral keflex.The device is not available for return.Additional information was requested, however is not available at this time.
 
Manufacturer Narrative
(b)(4).Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the review of the device history record (dhr) cannot be conducted.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.Limited information was provided by the reporter.The instructions for use (ifu) specifies, "use aseptic technique" "filling the on-q* pump: (figure 3) note: follow hospital protocols and applicable regulations for filling pump." in addition the ifu provides warnings and cautions regarding minimizing the risk for a possible infection.Per the ifu, warnings "remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter." cautions: "reuse of the device could result in the following risk: ¿ increased risk of infection." conclusions: the device was not returned to (b)(4) for evaluation, therefore we are unable to determine the cause for the reported event.Limited information was provided by the reporter.Multiple attempts were made to obtain additional information without success.The ifu provides warnings and cautions regarding minimizing the risk for a possible infection.Per the ifu, warnings "remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter." the ifu also cautions: "reuse of the device could result in the following risk: ¿ increased risk of infection." 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.
 
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Brand Name
ON-Q EXPANSION KIT SILVERSOAKER 2.5IN (6.5CM)
Type of Device
CATHETER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
HALYARD - IRVINE
43 discovery
suite 100
irvine CA 92618
Manufacturer (Section G)
AVENT S. DE R.L. DE C.V.
ave noruega edificio
fraccionamiento rubio
tijuana b.c. 2211 6
MX   22116
Manufacturer Contact
maria wagner
43 discovery
suite 100
irvine, CA 92618
9499232324
MDR Report Key4746138
MDR Text Key5885660
Report Number2026095-2015-00141
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK051401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/07/2015
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 Lay User/Patient
Device Model NumberPM010-A
Device Catalogue Number101353300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/07/2015
Initial Date FDA Received05/04/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ON-Q PUMP 400ML, 4ML/HR (2+2 DUAL SITE); MARCAINE 0.5%
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age28 YR
Patient Weight61
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