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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD-IRVINE ON-Q CATHETER SILVERSOAKER 1IN (2.5CM)

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HALYARD-IRVINE ON-Q CATHETER SILVERSOAKER 1IN (2.5CM) Back to Search Results
Model Number PM030-A
Device Problems Stretched (1601); Torn Material (3024)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
Procedure: total knee replacement ((b)(6) 2015).Cathplace: incisional.It was reported that an incident of a catheter stretching and breaking occurred.It was reported as, "a catheter was removed and appears stretched and potential remained fragments".The device is available for return.Additional information was received on (b)(4) 2015.It was reported that during the removal of the catheter by nursing student instructor, the catheter broke and appeared stretched.An x-ray was taken on (b)(6) 2015 for further evaluation of the possible retained catheter.
 
Manufacturer Narrative
(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis 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.Device return anticipated.
 
Manufacturer Narrative
Methods: the device was previously reported to be returning for an evaluation; however, it has subsequently been reported that the device will not be returned.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.The instructions for use (ifu) specifies the following: "warning: place catheter such that obstruction will not occur and catheter removal will not be impeded.Prior to final suturing, make sure catheter moves freely to ensure it¿s not caught in sutures.Assure that catheter is not in a vein or artery.Cautions: if resistance is encountered or catheter stretches, stop.Continued pulling could break the catheter.It¿s advisable to cover the site with warm compresses, and wait 30 to 60 minutes, and try again.The patient¿s body movements may relieve the catheter to allow easier removal.For additional information refer to the technical bulletin: tips for preventing in-situ catheter breakage with the on-q system.Do not cut or forcefully remove catheter.After removal, check distal end of catheter for black marking to ensure entire catheter was removed." conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.A technical bulletin (mk-00021) tips for preventing in-situ catheter breakage was sent to the customer.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 CATHETER SILVERSOAKER 1IN (2.5CM)
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 Key4654791
MDR Text Key21565133
Report Number2026095-2015-00125
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 Health Professional
Type of Report Initial,Followup
Report Date 03/18/2015
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? Yes
Device Operator Health Professional
Device Model NumberPM030-A
Device Catalogue Number101353700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2015
Initial Date FDA Received04/02/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/12/2015
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
Type of Device Usage Initial
Patient Sequence Number1
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