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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q CATHETER

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HALYARD - IRVINE ON-Q CATHETER Back to Search Results
Lot Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/26/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Method: the device was received for analysis.A visual inspection was performed.The reporter was unable to provide a lot number; therefore, the device history record (dhr) review 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.
 
Event Description
Procedure: left shoulder surgery ((b)(6) 2015).Cathplace: neck.It was reported that a patient's family member cut a catheter in error and a fragment was inside the patient.The patient's family member used scissors to try to remove the surgical dressing and cut the catheter.Approximately one inch of the catheter was retained inside the patient.The patient's family member was instructed to contact the anesthesiologist.The anesthesiologist instructed the patient's family member to pull out the remaining part of the catheter.It was reported that they "had no trouble getting it out." the patient's family member reported that she observed a black tip at the end of the catheter piece that was removed.The patient was in good condition following the event.Additional information was received on 06/30/2015.It was reported that when the patient's family member attempted to change the dressing, the tape was stuck to the patient and it would not easily pull off without hurting the patient.Therefore, the patient's family member used scissors to try to cut the gauze off.The catheter was accidently cut and about 3/4-1 inch of the catheter was showing outside of the patient.The patient is doing well.The catheter is available for return.
 
Manufacturer Narrative
Method: a visual observation was performed, and photographic images were taken of the returned device.Results: the visual inspection found that a pump was received with a green stingray in a closed position and the epimed catheter was received not fully intact.Only a portion of the catheter was returned.The catheter portion received was missing starting at the 2nd marking.Conclusion: the investigation summary concludes that the epimed catheter was received not fully intact; and missing a portion of the catheter starting at the 2nd marking.It was reported that the catheter was inadvertently cut with scissors while changing surgical dressing.Therefore, the root cause was determined to be the user.Based on this investigation, the complaint is confirmed.The device history record could not be reviewed as the model and lot number were unavailable.Information from this incident has been included in our product complaint trend reporting systems for monitoring, tracking and trending.
 
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Brand Name
ON-Q CATHETER
Type of Device
CATHETER
Manufacturer (Section D)
HALYARD - IRVINE
43 discovery
suite 100
irvine CA 92618
Manufacturer (Section G)
AVENT, INC.
6620 s. memorial place
suite 100
tucson AZ 85756
Manufacturer Contact
maria wagner
43 discovery
suite 100
irvine, CA 92618
9499232324
MDR Report Key4925478
MDR Text Key22506777
Report Number2026095-2015-00201
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Patient Family Member or Friend
Type of Report Followup
Report Date 06/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/20/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/08/2015
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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