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

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.

• 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 Key: 4925478
• MDR Text Key: 22506777
• Report Number: 2026095-2015-00201
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• 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 Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2015
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR