• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q EXPANSION KIT: SILVERSOAKER; CATHETERS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HALYARD - IRVINE ON-Q EXPANSION KIT: SILVERSOAKER; CATHETERS Back to Search Results
Model Number PM050-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemothorax (1896)
Event Date 09/29/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Method: the actual device was not returned.A review of the device history record (dhr) was not performed.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
 
Event Description
Fill volume: unknown, flow rate: unknown, procedure: truitt placement (left), cathplace: truitt placement (left).It was initially reported that a patient was admitted for trauma from falling down a cliff, and also had trauma to the clavicle, sternum, and rib.Two catheters were placed on the left side on (b)(6) 2016 at approximately t10 for multiple left side rib fractures.Surgery was necessary for the patient due to the location of one of the catheters into the left lung of the patient.The catheter was placed within the pleural cavity and had lower left lobe penetration.Currently, the patient has one catheter in since it was placed correctly.The most recent information received on 10-oct-2016 stated that the patient was discharged from the hospital without further details.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ON-Q EXPANSION KIT: SILVERSOAKER
Type of Device
CATHETERS
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 d-1b
fraccionamiento rubio
tijuana, b.c. 22116
MX   22116
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key6055731
MDR Text Key58358588
Report Number2026095-2016-00182
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,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 10/04/2016
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 NumberPM050-A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Other Device ID Number10680651135411
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/04/2016
Initial Date FDA Received10/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
TUNNELER INTRODUCER SHEATH
Patient Outcome(s) Required Intervention;
Patient Age20 YR
-
-